Postnatal parental education for optimizing infant general health and parent-infant relationships

  • Review
  • Intervention

Authors


Abstract

Background

Many learning needs arise in the early postpartum period, and it is important to examine interventions used to educate new parents about caring for their newborns during this time.

Objectives

The primary objective was to assess the effects of structured postnatal education delivered to an individual or group related to infant general health or care and parent-infant relationships.

Search methods

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2013).

Selection criteria

We included randomized controlled trials of any structured postnatal education provided to individual parents or groups of parents within the first two months post-birth related to the health or care of an infant or parent-infant relationships.

Data collection and analysis

Two review authors (JB, CTB) assessed trial quality and extracted data from published reports.

Main results

Of the 27 trials (3949 mothers and 579 fathers) that met the inclusion criteria, only 15 (2922 mothers and 388 fathers) reported useable data. Educational interventions included: five on infant sleep enhancement, 12 on infant behaviour, three on general post-birth health, three on general infant care, and four on infant safety. Details of the randomization procedures, allocation concealment, blinding, and participant loss were often not reported. Of the outcomes analyzed, only 13 were measured similarly enough by more than one study to be combined in meta-analyses. Of these 13 meta-analyses, only four were found to have a low enough level of heterogeneity to provide an overall estimate of effect. Education about sleep enhancement resulted in a mean difference of 29 more night-time minutes of infant sleep in 24 hours at six weeks of age (95% confidence interval (CI) 18.53 to 39.73) than usual care. However, it had no significant effect on the mean difference in minutes of crying time in 24 hours at six weeks and 12 weeks of age. Education related to infant behaviour increased maternal knowledge of infant behaviour by a mean difference of 2.85 points (95% CI 1.78 to 3.91).

Authors' conclusions

The benefits of educational programs to participants and their newborns remain unclear. Education related to sleep enhancement appears to increase infant sleep but appears to have no effect on infant crying time. Education about infant behaviour potentially enhances mothers' knowledge; however more and larger, well-designed studies are needed to confirm these findings.

摘要

产后双亲教育以促进婴儿健康与亲子关系

研究背景

产后初期产生了大量的学习需求,评价教育初为人父母者在此期间如何照顾新生儿的干预措施是非常重要的。

研究目的

主要研究目标为评估提供给个人或群体的结构化产后教育对婴儿健康和亲子关系的影响。

检索策略

研究检索了Cochrane妊娠和分娩组的试验注册库(the Cochrane Pregnancy and Childbirth Group's Trials Register,截止至2013年3月31日)。

标准/纳入排除标准

纳入产后前两个月内提供给个人或群体的结构化产后教育的随机对照试验,教育内容是有关婴儿照护和亲子关系的知识。

数据收集与分析

两位评价员(JB,CTB)评价试验的质量,并从已发表的报告中提取数据。

主要结果

27项试验(3949名母亲和579名父亲)符合纳入标准,其中只有15项试验(2922名母亲和388名父亲)提供了可用数据。教育干预内容包括:5项有关婴儿睡眠促进、12项有关婴儿行为、3项有关出生后健康、3项关于婴儿保健、4项有关婴儿安全。研究中通常没有对随机方法、分配隐藏、盲法和失访等详细信息进行报道。分析的结果指标中,只有13个结局指标被不止一项研究所采用,且测量方法相似,因此可做Meta分析进行合并。在这13个Meta-分析中,只有4个异质性较低,可以用来估计总体效应。与常规护理相比,睡眠促进教育使6周大的婴儿在24小时内的夜间睡眠时间平均增加了29分钟(95%可信区间(95%CI)18.53 - 39.73),而对6周大和12周大的婴儿24小时内哭泣时间的减少没有显著效果。婴儿行为教育增加了母亲有关婴儿行为的知识,其平均增加值为2.85分(95%CI=1.78 - 3.91)。

作者结论

睡眠促进教育似乎可以增加婴儿睡眠时间,但对婴儿哭泣时间没有明显效果,婴儿行为教育有可能增长了母亲的知识。然而,此结论仍需要更多更大样本、设计良好的研究加以验证。

翻译注解

更新译者:方赛男,审校:孙瑾,鲁春丽。北京中医药大学循证医学中心。2017年7月13日。原译者:中国循证卫生保健协作网。重庆医科大学公共卫生与管理学院,翻译时间:2012年

Résumé scientifique

Éducation parentale postnatale pour l'optimisation générale de la santé des nourrissons et des relations parent-nourrisson

Contexte

Les besoins d'apprentissage augmentent au tout début de la période post-partum et il est important d'examiner les interventions mises en place pour éduquer les nouveaux parents à prendre soin de leur nouveau-nés pendant cette période.

Objectifs

L'objectif principal était d'évaluer les effets de l'éducation post-natale structurée dispensée à une personne ou à un groupe liés à l'état de santé général d'un enfant ou des soins et les relations parent-nourrisson.

Stratégie de recherche documentaire

Nous avons effectué des recherches dans le registre des essais cliniques du groupe Cochrane sur la grossesse et la naissance (31 mars 2013).

Critères de sélection

Nous avons inclus des essais contrôlés randomisés portant sur toute éducation post-natale structurée dispensée à des parents individuels ou à des groupes de parents dans les deux premiers mois après l'accouchement sur la santé ou les soins à apporter au nourrisson ou les relations parent-nourrisson.

Recueil et analyse des données

Deux auteurs de la revue (JB, CTB) ont évalué la qualité des essais et extrait des données issues de rapports publiés.

Résultats principaux

En 27 essais (3949 mères et 579 pères) qui répondaient aux critères d'inclusion, seulement 15 (2922 mères et 402 pères) rapportaient des données d'utilité. Interventions éducatives inclues: Cinq sur l'amélioration du sommeil du nourrisson, 12 sur le comportement du nourrisson, trois sur la santé post-natale générale, trois sur les soins à apporter et quatre sur la sécurité du nourrisson. Les détails concernant les procédures de randomisation, l'assignation secrète, la mise en aveugle et les participants perdus de vue étaient rarement indiqués. Parmi les résultats analysés, 13 seuls ont été mesurés suffisamment similaires par plus d'une étude pour pouvoir être combinés en méta-analyses. Sur ces 13 méta-analyses, seules quatre se sont avérées avoir un niveau d'hétérogénéité suffisamment bas pour fournir une estimation globale d'effet. L'éducation sur l'amélioration du sommeil s'est traduite par une différence moyenne de 29 minutes supplémentaires de sommeil nocturne du nourrisson par 24 heures à l'âge de six semaines (intervalle de confiance (IC à 95%, de 18,53 à 39,73) comparativement aux soins habituels. Cependant, il n'avait aucun effet significatif sur la différence moyenne de minutes de la durée des pleurs en 24 heures à six et 12 semaines d'âge. L'éducation des mères sur le comportement des nourrissons a augmenté leurs connaissances en la matière avec une différence moyenne de 2,85 points (IC à 95%, de 1,78 à 3,91).

Conclusions des auteurs

Les effets bénéfiques des programmes éducatifs pour les participants et leurs nouveau-nés restent à éclaircir. L'éducation liée à l'amélioration du sommeil semble entraîner une augmentation du sommeil du nourrisson, mais elle ne semble avoir aucun effet sur la durée des pleurs. L'éducation sur le comportement du nourrisson peut potentiellement accroître les connaissances des mères, cependant d'avantage d'études et de plus grande échelle; des études bien planifiées sont nécessaires pour confirmer ces résultats.

Plain language summary

Postnatal parental education for optimizing infant general health and parent-infant relationships

The benefits of post-birth parental education for infant health or care and parent-infant relationships remain unclear.

Parenting is important in the development of healthy children. New parents have much to learn soon after the birth of an infant and parents do not always have social support or role models to follow. This makes it essential to examine the effectiveness of interventions used by health personnel to educate new parents about caring for their newborn infants in the best possible way. This review sought to assess educational programs delivered to one or both parents individually or in a group in the first two months after birth. Although the review identified 27 trials involving 3949 mothers and 579 fathers, only 15 (2922 mothers and 388 fathers) provided useable data on outcomes of interest. Infant sleep, crying, and maternal knowledge of infant behaviours were the only outcomes that could be effectively analyzed. Results showed that educational interventions aimed at sleep enhancement increased the amount of infant sleep by an average of 29 minutes in 24 hours but had no significant effect on the average infant crying time in 24 hours at six weeks and 12 weeks of age. Education on infant behaviour increased mothers' knowledge of infant behaviour four weeks after birth by an average of 2.85 points. Further research is required.

概要

产后双亲教育对婴儿健康与亲子关系的益处仍不清楚。

教育计划对参与的父母及其新生儿的好处仍然不清楚。

在孩子健康成长的过程中,父母的角色是非常重要的。初为人父母者在喜获孩子后有许多需要学习之处,然而他们并不总是能够获得社会支持或有范例可以遵循。因此,对于由专业人士提供给初为人父母者照顾新生儿的教育措施,评估其效果是很必要的。本系统评价试图评估在产后8周内提供给父母一方或双方,或家长团体的教育计划的效果。本系统评价纳入了27个试验,共涉及3949位母亲和579位父亲,但只有15个试验(2922位母亲和388位父亲)提供了结局指标相关的可用数据。婴儿睡眠时间和母亲对婴儿行为知识的掌握是仅有的两个可以进行有效分析的结局指标。结果显示,睡眠促进教育干预使婴儿睡眠在24小时内平均增加了29分钟,对婴儿哭泣时间没影响;婴儿行为教育使母亲在产后四周有关婴儿行为的知识平均增加了2.85分。但仍需要进一步的研究来证实这些结论。

翻译注解

更新译者:方赛男,审校:孙瑾,鲁春丽。北京中医药大学循证医学中心。2017年7月13日。原译者:中国循证卫生保健协作网。重庆医科大学公共卫生与管理学院,翻译时间:2012年

Résumé simplifié

Éducation parentale postnatale pour l'optimisation générale de la santé des nourrissons et des relations parent-nourrisson

Les bénéfices de l'éducation parentale post-natale pour la santé des nourrissons ou pour les soins de santé et les relations parent-nourrisson restent indéterminés.

La parentalité est importante dans le développement d'enfants en bonne santé. Les nouveaux parents ont beaucoup à apprendre peu après la naissance d'un enfant et n'ont pas toujours un soutien social ou un modèle parental à imiter. Il est donc essentiel d'examiner l'efficacité des interventions mises en place par le personnel de santé pour éduquer les nouveaux parents à prendre soin de leur nouveau-nés de la meilleure façon possible. Cette revue cherchait à évaluer les programmes éducatifs proposés aux deux parents ou à l'un d'eux ou encore à un groupe de parents dans les deux premières mois après la naissance. Bien que la revue ait identifié 27 essais portant sur 3949 mères et 579 pères, seulement 15 (2922 mères et 402 pères) avaient des données utilisables avec résultats d'intérêt. Le sommeil du nourrisson, les pleurs, et les connaissances maternelles sur les comportements du nourrisson ont été les seuls résultats qui pouvaient être analysés efficacement. Des résultats ont montré que les interventions éducatives destinées à l'amélioration du sommeil augmentaient la quantité de sommeil du nourrisson en une moyenne de 29 minutes en 24 heures, mais n'avait aucun effet significatif sur la moyenne des pleurs du nourrisson en 24 heures à six et 12 semaines d'âge. L'éducation sur le comportement du nourrisson a augmenté les connaissances des mères sur le comportement du nourrisson quatre semaines après la naissance, de 2,85 points en moyenne. Des recherches supplémentaires sont nécessaires.

Notes de traduction

Traduit par: French Cochrane Centre 14th January, 2014
Traduction financée par: Ministère du Travail, de l'Emploi et de la Santé Français

Laički sažetak

Edukacija roditelja nakon rođenja djeteta za optimalno opće zdravstveno stanje novorođenčadi i povezanost roditelja i djece

Nije jasno ima li od edukacije roditelja nakon porođaja koristi za zdravlje i njegu novorođenčadi, te djeluje li ta edukacija blagotvorno na povezanost između roditelja i novorođenčadi.

Roditeljstvo je važno u razvoju zdrave djece. Novopečeni roditelji imaju mnogo toga za naučiti odmah poslije poroda djeteta, a nemaju uvijek potporu društva ili uzore koje bi mogli pratiti. Stoga je vrlo važno ispitati kakav utjecaj imaju intervencije koje zdravstveni djelatnici koriste kako bi educirali nove roditelje o tome kako se skrbiti za novorođenče na najbolji mogući način. Ovaj Cochrane sustavni pregled procijenio je programe edukacije za jednog ili oba roditelja pojedinačno ili u grupi, u prva dva mjeseca nakon rođenja. Iako je sustavnim pregledom literature pronađeno 27 istraživanja koja uključuju 3949 majke i 579 očeva, samo 15 istraživanja (2922 majke i 388 očeva) dalo je upotrebljive podatke o ishodima koji su za ovaj sustavni pregled bili od interesa. Spavanje, plakanje i majčino poznavanje ponašanja novorođenčadi bili su jedini ishodi koje je moguće djelotvorno analizirati. Rezultati su pokazali da su edukativne intervencije usmjerene na poboljšanje spavanja povećale količinu sna u novorođenčadi u prosjeku za 29 minuta u 24 sati, ali nisu imala značajan utjecaj na prosječni plač djeteta unutar 24 sati kod dojenčadi između 6 i 12 tjedana starosti. Edukacija o ponašanju djeteta povećala je znanje majki o ponašanju dojenčadi četiri tjedna nakon poroda u prosjeku za 2,85 bodova. Potrebna su daljnja istraživanja na ovu temu.

Bilješke prijevoda

Cochrane Hrvatska
Prevela: Lidija Posavec
Ovaj sažetak preveden je u okviru volonterskog projekta prevođenja Cochrane sažetaka. Uključite se u projekt i pomozite nam u prevođenju brojnih preostalih Cochrane sažetaka koji su još uvijek dostupni samo na engleskom jeziku. Kontakt: cochrane_croatia@mefst.hr

Background

Description of the condition

Parenting is recognized as a key determinant in fostering healthy child development (CCCF 2001; Maas 2012). Current research on brain sculpting emphasizes the important role that parenting plays in the development of the infant brain following birth and on into childhood. At this time, the brain is creating neural pathways that help to ensure lifelong good health, and it is important to provide the best possible environment for this growth (CCCF 2001; McCain 2011; Mustard 2008). Infancy is a distinctive period and a formative phase in human development and parents play a central role in an infant’s physical survival, cognitive development, emotional maturation, and social growth (Bornstein 2002; Dusing 2012). Four interconnected factors have been identified as key to creating a positive environment for infant brain development after birth: (a) protection from harm, (b) healthy attachment, (c) responsive care, and (d) breast milk/breastfeeding (CCCF 2001). The first three are the primary focus of this review.

The transition to parenting is an exciting yet stressful time (de Montigny 2008), and many learning needs arise in the early postpartum period. In order for parents to be competent and confident in their parenting role, they must acquire new knowledge and skills (Mercer 2006). Many new parents may not have the social support or role models readily available to them to teach them positive parenting behaviours (Wilkins 2006). Education by health personnel has the potential to play a key role in assisting new parents in their parenting efforts.

Description of the intervention

In developed countries, education for new parents is most often provided by nurses, midwives, and physicians. It can be hospital- or community-based and takes on many forms, using a variety of teaching-learning methods. Educational interventions can be directed towards individuals or groups and can be provided face-to-face, by phone, through print media, or by DVD, for example (Murray 2010). Educational interventions are offered at different times in the early postpartum period and are of varying lengths. Interventions include mothers, fathers, or both parents. There is great variation in the topics covered including: newborn care, feeding, and preventive care (e.g., positioning, car seat use, vaccination, smoke detector use); normal infant behaviour and development (e.g., crying and sleeping); and maternal/paternal and infant interaction (Brown 2006; Murray 2010).

How the intervention might work

To parent effectively, parents not only need knowledge and skills of appropriate parenting behaviours, but also need to have the confidence in their ability to carry out these behaviours (Bandura 1989; de Montigny 2008). It is conceivable that educational interventions will enhance parenting behaviours by addressing knowledge and skill deficits, as well as increasing parental confidence and competence. Indeed, studies of various postnatal educational interventions have demonstrated that they have been effective in improving parenting and infant outcomes such as: maternal-infant interaction; infant language development; parental attitudes and knowledge (Mercer 2006); paternal competence in parenting, including fostering infant cognitive growth and sensitivity to infant cues (Magill-Evans 2007); and usage of infant healthcare resources (El-Mohandes 2003).

Why it is important to do this review

The key to healthy child development is positive parenting. It is important to examine how positive parenting is enacted. One avenue for exploration is the role that postnatal education plays in the transition to parenting. It is important to examine the current interventions being used to educate new parents in their parenting role postdischarge. Do educational interventions promote optimal infant health and care and parent-infant relationships, and if they do, what is the best approach to this education? Because of the variety of approaches and topics covered, it is important to capture the heterogeneous nature of postpartum education in conducting a systematic review of its effects. This review will include reports of interventions with a variety of objectives, content, timing, and teaching-learning methods/media employed, offered to a variety of populations, in a variety of formats. The review will be broad, rather than specific, in an attempt to determine if there is any effect of any structured postnatal educational intervention with any population. This review aims to systematically search for and combine all evidence currently available from randomized controlled trials of the effects of structured postnatal education on infant general health or care and parent-infant relationships including: infant growth and development, crying, and sleeping; infant preventive care; maternal/paternal knowledge acquisition; maternal/paternal infant care confidence; maternal/paternal-infant interaction, and maternal/paternal stress/anxiety.

Objectives

The primary objective was to assess the effects of structured postnatal education delivered to an individual or group related to infant general health or care and parent-infant relationships.

A secondary objective was to determine whether the effects of structured postnatal education vary by length or type of intervention and by population.

Methods

Criteria for considering studies for this review

Types of studies

We considered studies if they met the following inclusion criteria: randomized controlled trials (RCTs) evaluating structured forms of postnatal education provided to individual parents or groups of parents; random allocation to treatment and control groups; violations of allocated management insufficient to materially affect outcomes; and loss to follow-up insufficient to materially affect outcomes. We considered studies that involved individual- or cluster randomization eligible for inclusion. We excluded cross-over trials and quasi-RCTs.

Types of participants

We included studies of one or both parents of a living infant. We excluded studies of educational interventions for parents of infants in a neonatal intensive care unit and parents less than 20 years old, because the needs of these families differ substantially from those of other families.

Types of interventions

We included studies of any structured educational intervention (using a variety of methods/media), offered either in hospital or elsewhere within the first two months post birth to individuals or groups by an educator (nurse, nurse practitioner, midwife, physician, or other), related to the general health or care of an infant or to parent-infant relationships. We excluded studies of interventions that were primarily support-based.

Types of outcome measures

General infant health, infant care, or parent-infant relationship factors, as measured by the researchers, that could be affected by postnatal education.

Primary outcomes
  1. Infant growth and development;

  2. infant crying;

  3. infant sleeping;

  4. infant preventive care (e.g., infant positioning, infant car seat use, smoke detector use, infant vaccination).

Secondary outcomes
  1. Maternal/paternal knowledge acquisition;

  2. maternal/paternal care confidence;

  3. maternal/paternal-infant interaction;

  4. maternal/paternal stress/anxiety.

Search methods for identification of studies

Electronic searches

We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register by contacting the Trials Search Co-ordinator (31 March 2013). 

The Cochrane Pregnancy and Childbirth Group’s Trials Register is maintained by the Trials Search Co-ordinator and contains trials identified from: 

  1. monthly searches of the Cochrane Central Register of Controlled Trials (CENTRAL);

  2. weekly searches of MEDLINE;

  3. weekly searches of Embase;

  4. handsearches of 30 journals and the proceedings of major conferences;

  5. weekly current awareness alerts for a further 44 journals plus monthly BioMed Central email alerts.

Details of the search strategies for CENTRAL, MEDLINE and Embase, the list of handsearched journals and conference proceedings, and the list of journals reviewed via the current awareness service can be found in the ‘Specialized Register’ section within the editorial information about the Cochrane Pregnancy and Childbirth Group

Trials identified through the searching activities described above are each assigned to a review topic (or topics). The Trials Search Co-ordinator searches the register for each review using the topic list rather than keywords.  

For details of the search strategies used in the previous version of this review, see Appendix 1.

Data collection and analysis

For the methods used when assessing the trials identified in the previous version of this review, see Bryanton 2010.

For this update we used the following methods when assessing the reports identified by the updated search.

Selection of studies

The first and second review authors independently assessed for inclusion all the potential studies we identified as a result of the search strategy. We resolved any disagreement through discussion.

Data extraction and management

We used an adaptation of 'The Cochrane Pregnancy Childbirth Group Data Extraction Template' to extract data. For eligible studies, both review authors extracted the data using the adapted template. We resolved discrepancies through discussion. We entered data into Review Manager software (RevMan 2012) and checked them for accuracy. The first author attempted to contact two authors of the original reports to secure useable data. One did not respond and the other chose not to provide the data.

Assessment of risk of bias in included studies

Two review authors independently assessed risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions ( Higgins 2011 ). We resolved any disagreement by discussion.

(1) Random sequence generation (checking for possible selection bias)

We described for each included study the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.

We assessed the method as:

  • low risk of bias (any truly random process, e.g., random number table; computer random number generator);

  • high risk of bias (any non-random process, e.g., odd or even date of birth; hospital or clinic record number);

  • unclear risk of bias.   

(2) Allocation concealment (checking for possible selection bias)

We described for each included study the method used to conceal allocation to interventions prior to assignment and assessed whether intervention allocation could have been foreseen in advance of, or during recruitment, or changed after assignment.

We assessed the methods as:

  • low risk of bias (e.g., telephone or central randomization; consecutively numbered sealed opaque envelopes);

  • high risk of bias (open random allocation; unsealed or non-opaque envelopes, alternation; date of birth);

  • unclear risk of bias.   

(3.1) Blinding of participants and personnel (checking for possible performance bias)

We described for each included study the methods used, if any, to blind study participants and personnel from knowledge of which intervention a participant received. We considered that studies were at low risk of bias if they were blinded, or if we judged that the lack of blinding would be unlikely to affect results. We assessed blinding separately for different outcomes or classes of outcomes.

We assessed the methods as:

  • low, high or unclear risk of bias for participants;

  • low, high or unclear risk of bias for personnel.

(3.2) Blinding of outcome assessment (checking for possible detection bias)

We described for each included study the methods used, if any, to blind outcome assessors from knowledge of which intervention a participant received. We assessed blinding separately for different outcomes or classes of outcomes.

We assessed methods used to blind outcome assessment as:

  • low, high or unclear risk of bias.

(4) Incomplete outcome data (checking for possible attrition bias due to the amount, nature and handling of incomplete outcome data)

We described for each included study, and for each outcome or class of outcomes, the completeness of data including attrition and exclusions from the analysis. We stated whether attrition and exclusions were reported and the numbers included in the analysis at each stage (compared with the total randomized participants), reasons for attrition or exclusion where reported, and whether missing data were balanced across groups or were related to outcomes. 

We assessed methods as:

  • low risk of bias (e.g., no missing outcome data; < 20% missing outcome data; missing outcome data balanced across groups);

  • high risk of bias (e.g., > 20% missing outcome data; numbers or reasons for missing data imbalanced across groups; ‘as treated’ analysis done with substantial departure of intervention received from that assigned at randomization);

  • unclear risk of bias.

(5) Selective reporting (checking for reporting bias)

We described for each included study how we investigated the possibility of selective outcome reporting bias and what we found.

We assessed the methods as:

  • low risk of bias (where it is clear that all of the study’s pre-specified outcomes and all expected outcomes of interest to the review have been reported);

  • high risk of bias (where not all the study’s pre-specified outcomes have been reported; one or more reported primary outcomes were not pre-specified; outcomes of interest are reported incompletely and so cannot be used; study fails to include results of a key outcome that would have been expected to have been reported);

  • unclear risk of bias.

(6) Other bias (checking for bias due to problems not covered by (1) to (5) above)

We described for each included study any important concerns we had about other possible sources of bias.

We assessed whether each study was free of other problems that could put it at risk of bias:

  • low risk of other bias;

  • high risk of other bias;

  • unclear whether there is risk of other bias.

(7) Overall risk of bias

We made explicit judgements about whether studies were at high risk of bias, according to the criteria given in the Cochrane Handbook (Higgins 2011). With reference to (1) to (6) above, we assessed the likely magnitude and direction of the bias and whether we considered it is likely to impact on the findings. We explored the impact of the level of bias through undertaking sensitivity analyses when feasible.

Measures of treatment effect

Dichotomous data

For dichotomous data, we presented results as summary risk ratios with 95% confidence intervals. 

Continuous data

For continuous data, we used the mean difference if outcomes were measured in the same way between trials. We planned to use the standardized mean difference to combine trials that measured the same outcome, but used different methods. We used the generic inverse variance method when original studies provided estimates of the intervention effect (mean differences) and standard errors rather than the means for each group.

Unit of analysis issues

Cluster-randomized trials

We identified no cluster-randomized trials for inclusion in this review. Cluster-randomized trials would have been included in the analyses along with individually-randomized trials. We planned to adjust their sample sizes using the methods described in the Cochrane Handbook (section 16.3.4) using an estimate of the intra-cluster correlation co-efficient (ICC) derived from the trial (if possible), from a similar trial or from a study of a similar population. If we used ICCs from other sources, we planned to report this and conduct sensitivity analyses to investigate the effect of variation in the ICC. If we identified both cluster-randomized trials and individually-randomized trials, we planned to synthesize the relevant information. We would consider it reasonable to combine the results from both if there was little heterogeneity between the study designs and the interaction between the effect of intervention and the choice of randomization unit was considered to be unlikely. We planned to acknowledge heterogeneity in the randomization unit and perform sensitivity analyses to investigate the effects of the randomization unit.

Cross-over trials

Cross-over trials were not eligible for inclusion in this review due to the nature of the intervention.

Dealing with missing data

For included studies, we noted levels of attrition. We explored the impact of including studies with high levels of missing data in the overall assessment of treatment effect by using sensitivity analysis when feasible. For all outcomes, we carried out analyses using available case analysis.

Assessment of heterogeneity

We assessed statistical heterogeneity in each meta-analysis using the Tau², I² and Chi² statistics. We regarded heterogeneity as substantial if an I² was greater than 30% and either a Tau² was greater than zero, or there was a low P value (less than 0.10) in the Chi² test for heterogeneity. 

Assessment of reporting biases

There were no meta-analyses with 10 or more studies. If there had been 10 or more studies in the meta-analysis, we planned to investigate reporting biases (such as publication bias) using funnel plots. We would have assessed funnel plot asymmetry visually. If asymmetry was suggested by a visual assessment, we planned to perform exploratory analyses to investigate it.

Data synthesis

We carried out statistical analysis using the Review Manager software (RevMan 2012). We used fixed-effect meta-analysis for combining data where it was reasonable to assume that studies were estimating the same underlying treatment effect: i.e., where trials were examining the same intervention and the trials’ populations and methods were judged sufficiently similar. When substantial heterogeneity was identified in a fixed-effect meta-analysis, we repeated the analysis using a random-effects method and compared the results.

Subgroup analysis and investigation of heterogeneity

We planned to carry out the following subgroup analyses:    

  1. specific class content (e.g., childcare, parenthood);

  2. specific teaching approaches (e.g., didactic, experiential);

  3. format of interventions (e.g., one-to-one in hospital/home, telephone, information line, outpatient clinic, group);

  4. age of infant at time of intervention;

  5. effects in specific populations (e.g., low income, multi-ethnic).

We planned to use the following outcomes in subgroup analysis:

  1. infant growth and development;

  2. infant crying;

  3. infant sleeping;

  4. infant preventive care (e.g., infant positioning, infant car seat use, smoke detector use, infant vaccination).

We planned to assess subgroup differences by interaction tests available within RevMan (RevMan 2012). We planned to report the results of subgroup analyses quoting the Chi² statistic and P value and the interaction test I² value.

Sensitivity analysis

We carried out sensitivity analyses to explore the effects of trial quality and outcomes with statistical heterogeneity.

Results

Description of studies

Results of the search

The search was updated and four new studies were included (Issler 2009; McRury 2010; Paradis 2011; Paul 2011). Twenty-three studies were excluded. One study was left in awaiting classification; it had no English translation so we were unable to assess if it was a RCT (Kim 2004). One study was left in ongoing studies as it was a study protocol and was not completed (Cook 2012). Eligibilty criteria were reviewed and clarified. Two studies were excluded from the original review because they included an antenatal education component that could not be separated from the postnatal one and upon clarification of eligibility criteria, they were deemed not eligible (Doherty 2006; Wolfson 1992). Outcomes were reviewed and clarified. Maternal/paternal infant care competence was deleted because it overlapped infant preventive care and maternal/paternal care confidence. It was replaced by maternal/paternal stress/anxiety.

Included studies

In this update, a total of 27 trials, involving 3949 mothers and 579 fathers, met the study inclusion criteria; however only 15 of these (2922 mothers and 388 fathers) reported useable data on outcomes of interest. Twenty-one studies were conducted in the United States, two in Brazil, and one each in Australia, Canada, Nepal, and the United Kingdom. Trials directed towards women or couples included: five testing education relative to sleep enhancement, 12 testing education relative to infant behaviour, three testing education relative to general post-birth health, three testing education relative to general infant care, four testing education relative to infant safety.

Excluded studies

We excluded a total of 39 studies in this update.

Risk of bias in included studies

The vast majority of the included studies were of uncertain quality, since details of the randomization procedure, allocation concealment, blinding of outcome assessors or participant accrual/loss, or both, were often not reported or were unclear. Many studies had substantial attrition (greater than 20%).

See Figure 1 and Figure 2 for a summary of 'Risk of bias' assessments.

Figure 1.

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Figure 2.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

Allocation

Forty-four per cent (n = 12) of studies reported random sequence generation; whereas for 56% (n = 15) the risk of selection bias was unclear. Twenty-six per cent (n = 7) described allocation concealment; however the risk of selection bias was unclear for 70% (n = 19) of studies and high for 4% (n = 1).

Blinding

In 15% (n = 4) of studies, there was blinding of participants and or personnel; whereas the risk of performance bias was unclear for 66% (n = 18) of studies and high in 19% (n = 5). Fourty-four per cent (n = 12) of studies reported blinding of outcome assessment; however 37% (n = 10) of studies had an unclear risk of detection bias and 19% (n = 5) were judged to have a high risk of bias.

Incomplete outcome data

Thirty per cent (n = 8) of studies reported complete outcome data; whereas 44% (n = 12) had an unclear risk of attrition bias and 26% (n = 7) had a high risk due to incomplete outcome data.

Selective reporting

In 63% (n = 17) of studies there was complete reporting on all outcomes; however there was an unclear risk of reporting bias in 15% (n = 4) of studies and a high risk in 22% (n = 6).

Other potential sources of bias

The majority of studies (63%; n = 17) were deemed as having a low risk of other sources of bias; whereas in 30% (n = 8) there was an unclear risk and in 7% (n = 2) there was a high risk.

Effects of interventions

Of the 15 trials that presented useable data, outcomes differed considerably from one to the next. Four trials testing education relative to sleep enhancement presented data on two primary outcomes and one secondary outcome using 20 different outcome measures; these included assessments of infants at four, six, eight, and 12 weeks. The five studies testing education relative to infant behaviour presented outcome data on the four secondary outcomes using eight outcome measures; these with infants aged one to four days and four weeks. The two studies testing education relative to general infant post-birth health or care presented data on two primary outcomes and one secondary outcome using eight different outcome measures; these included infants aged up to six months. The four studies testing education relative to infant safety presented outcome data on two primary outcomes and one secondary outcome using four outcome measures, with infants from a few days to six weeks, three months, and six months of age.

Studies measured the effects of education on all primary outcomes (infant growth and development, infant crying, infant sleeping, and infant preventive care) as well as all secondary outcomes (parental knowledge acquisition, parental care confidence, parental-infant interaction, and parental stress/anxiety) using 40 different outcome measures at many different times postpartum. Only 13 outcomes were measured similarly enough by more than one study to be combined in meta-analyses. Of these 13, we found only four to have a low enough level of heterogeneity to provide a reliable overall estimate of effect.

1. Education on sleep enhancement versus usual care

Primary outcomes

Infant sleeping was measured in four studies in a total of 12 different ways. Education on sleep enhancement resulted in a mean difference (MD) of 29 more night-time minutes of sleep in 24 hours (95% confidence interval (CI) 18.53 to 39.73) at six weeks of age than usual care (Analysis 1.3.1). It should be noted, however, that the size of the two studies (Stremler 2006; Symon 2005) differed considerably, so that over 90% of the weighted results in this meta-analysis are due to the Symon 2005 study. This study had greater than 20% attrition. Symon 2005 also found a beneficial effect of the intervention on total infant sleep greater than or equal to 15 hours per 24 hours (risk ratio (RR) at six weeks 1.72; 95% CI 1.56 to 1.90; and at 12 weeks RR 1.73; 95% CI 1.54 to 1.95) (Analysis 1.1). Stremler 2006 reported that at six weeks, infants in the intervention group had significantly fewer night-time awakenings (MD 4.40; 95% CI 1.40 to 7.60) and longer maximum lengths of uninterrupted night-time sleep (MD 46 minutes; 95% CI 4.51 to 87.49) (Analysis 1.4.1). Two additional studies (McRury 2010; St James-Roberts 2001) did not find any meaningful or statistically significant effect of a sleep enhancement educational intervention on any of the infant sleep outcome measures at any period of time.

A second primary outcome measured in an educational intervention on sleep enhancement resulted in no significant difference in the mean crying time in 24 hours at six weeks (MD 4.36 minutes; 95% CI -6.44 to 15.16) (Analysis 1.7.2) and at 12 weeks (MD 0.55 minutes; 95% CI -8.38 to 9.47) (Analysis 1.7.4). The size of these two studies (McRury 2010; Symon 2005) differed considerably with 95% and 99% of the weighted results of this meta-analysis due to Symon 2005. Both studies had greater than 20% attrition. Symon 2005, McRury 2010, and St James-Roberts 2001 did not find any statistically significant effect of a sleep enhancement educational intervention on any of the seven infant crying outcome measures at any of the time periods.

Secondary outcomes

McRury 2010 examined the effect of a sleep enhancement intervention on maternal stress at six and 12 weeks. There were no differences between groups at six weeks and at 12 weeks the intervention group had significantly higher stress sores than the control (MD 36.40; 95%CI 15.38 to 57.42) (Analysis 1.20.2).

2. Education on infant behaviour versus usual care

Primary outcomes

No primary outcomes were assessed by interventions related to education on infant behaviour.

Secondary outcomes

Five studies testing education related to infant behaviour examined the four secondary outcomes in eight different ways. Education about infant behaviour resulted in an increase in maternal knowledge acquisition of infant behaviour at four weeks postpartum by a mean difference in score of 2.85 points (95% CI 1.78 to 3.91) (Analysis 2.1.2). The weighted results of the two studies in this meta-analysis were comparable (Golas 1986; Myers 1982). Myers 1982 reported a mean difference in score on maternal knowledge of infant behaviour of 2.50 points (95% CI 1.01 to 3.99); whereas Golas 1986 found a mean difference of 3.20 points (95% CI 1.68 to 4.72). Myers 1982 also reported a significant difference in knowledge for mothers (MD 4.60 points; 95% CI 2.60 to 6.60) (Analysis 2.1.1) and for fathers (MD 6.50 points; 95% CI 4.88 to 8.12) (Analysis 2.1.3) at one to four days postpartum, and for fathers at four weeks postpartum (MD 3.70 points; 95% CI 1.93 to 5.47) (Analysis 2.1.4). Maternal/paternal infant care confidence was measured by maternal confidence in interpreting infant behaviour by Golas 1986, with no significant difference noted between the intervention and control group. Another study (Wendland-Carro 1999) related to education about infant behaviour, found beneficial effects on maternal responsiveness at one month postpartum. Maternal visual and vocal synchronous co-occurrences during free play were significantly greater in the intervention group (MD 10.10; 95% CI 5.96 to 14.24) (Analysis 2.5) and (MD 6.73; 95% CI 3.64 to 9.82) (Analysis 2.6), respectively. Two other studies did not find any significant effect of education related to infant behaviour on any outcomes (Flagler 1988; Hall 1980).

3. Education on general post-birth infant health or care

Primary outcomes

An educational intervention about general post-birth infant health and care was examined with respect to its effect on infant growth and development in a single study (Bolam 1998), using infant weight, length, and head circumference as measures. Infant preventive care, represented by appropriate immunization, was also assessed in this study. No differences were found between groups on either primary outcome as a result of the intervention.

Secondary outcomes

Four measures of maternal knowledge acquisition were used in two studies (Bolam 1998; Regan 1995) to test the effects of educational interventions related to post-birth infant health and care. No significant differences were found in either study on any of the measures.

4. Education on infant safety versus usual care

Primary outcomes

Infant preventive care was measured three different ways in four studies testing education related to infant safety. Education related to prevention of tap water burns was effective in the single study that examined this (Shapiro 1987) (RR for greater use of temperature testing 1.76; 95% CI 1.43 to 2.17) (Analysis 4.3). Issler 2009 reported that an educational session for mothers on infant sleep position significantly increased the prevalence of supine position for infant sleep at three months (RR 1.79; 95% CI 1.17 to 2.72) (Analysis 4.4.3) and at six months post-birth (RR 2.18; 95% CI 1.35 to 3.53) (Analysis 4.4.4). Goetter 2005 also found a significant effect on sleep position at one week post-birth (RR 1.31; 95% CI 1.00 to 1.72) (Analysis 4.4.1) but found no effect at six weeks. Beneficial effects were reported in the one study that examined education regarding car seat safety. Christophersen 1982 found that the intervention parents used greater infant car seat restraint by a lap belt on hospital discharge (RR 21.00; 95%, CI 1.34 to 328.86) (Analysis 4.1.1) than the control parents. This effect was no longer significant at four to six weeks.

Secondary outcomes

Maternal knowledge acquisition was measured in one study related to infant safety (Shapiro 1987). Education related to prevention of tap water burns was effective in increasing post-hospitalization awareness of tap water burns (RR 1.07; 95% CI 1.04 to 1.11) (Analysis 4.2).

Subgroup analyses

These could not be carried out due to an insufficient number of comparable trials.

Sensitivity analyses

For the nine meta-analyses having high statistical heterogeneity (I² greater than 30%), we carried out sensitivity analyses exploring the differences between fixed-effect and random-effects methods; for four of these, the overall estimate of effect changed from being significant to non-significant. The other five that were non-significant did not change. Other sensitivity analyses were carried out on one meta-analysis of three studies (See Outcome 1.2.2: Total minutes of infant sleep in 24 hours at six weeks). Two studies that had greater than 20% attrition (McRury 2010; Symon 2005) were removed from the meta-analysis one at a time. When McRury 2010 was removed, high statistical heterogeneity remained. When Symon 2005 was removed, the heterogeneity was reduced to I² = 0%; however the overall estimate of effect changed from being significant to non-significant.

Discussion

Summary of main results

Of the 27 trials (3949 mothers and 579 fathers) that met the inclusion criteria, only 15 (2922 mothers and 388 fathers) reported useable data. Educational interventions included: five on infant sleep enhancement, 12 on infant behaviour, three on general post-birth health, three on infant care, and four on infant safety. Of the outcomes analyzed, only 13 were measured similarly enough by more than one study to be combined in meta-analyses. Of these 13 meta-analyses, only four were found to have a low enough level of heterogeneity to provide an overall estimate of effect. Education about sleep enhancement resulted in a mean difference of 29 more night-time minutes of infant sleep in 24 hours at six weeks of age (95% CI 18.53 to 39.73) than usual care. However, it had no significant effect on the mean difference in minutes of crying time in 24 hours at six weeks and 12 weeks of age. Education related to infant behaviour increased maternal knowledge of infant behaviour by a mean difference of 2.85 points (95% CI 1.78 to 3.91). With the exception of these four meta-analyses, the benefits of educational programs to participants and their newborn infants remain unclear. Interestingly, only four of the 15 studies reporting useable data assessed whether additional knowledge was acquired as a result of an educational intervention, and of these, only two found an effect.

Overall completeness and applicability of evidence

The usual benefit of meta-analyses for increasing statistical power by combining small studies was not achieved, since, with the exception of six studies (Golas 1986; McRury 2010; Myers 1982; St James-Roberts 2001; Stremler 2006; Symon 2005), the remaining nine studies were testing the effect of an intervention on one or more different outcomes at different lengths of time post-birth. This extensive heterogeneity of study outcomes permitted us to perform limited sensitivity analyses to test the effects of including studies of varying methodological quality. We were also unable to perform subgroup analyses to examine the effects of: specific class content, teaching approaches, interventions formats, age of infant at time of intervention, or effects in specific population groups.

Quality of the evidence

The trials were of small to moderate size. The vast majority of the included studies were of uncertain quality, since details of the randomization procedure, allocation concealment, blinding of outcome assessors or participant accrual/loss, or both, were often not reported or unclear. Many studies had substantial attrition (greater than 20%).

Potential biases in the review process

The review authors are not aware of any potential biases in the review process. We clarified inclusion criteria, as well as outcomes, which helped to create a more consistent result with respect to the study objective and time frame for the educational intervention.

Agreements and disagreements with other studies or reviews

The review authors are not aware of other systematic reviews related to postnatal education with the same focus on interventions, outcomes, and time frame as the current review. Individual RCTs have found beneficial effects of postnatal parental education on infant sleep (Stremler 2006; Symon 2005); maternal knowledge (Golas 1986; Myers 1982); and infant safety (Christophersen 1982; Goetter 2005; Issler 2009; Shapiro 1987) as reported in this review; whereas others have shown no beneficial effect. The most consistent evidence appears to be related to the positive effect of education on infant safety early postnatally; however, we were unable to confirm this finding through meta-analyses. There also appears to be little effect of education on infant crying. Other studies of various postnatal educational interventions using various designs have demonstrated that they have been effective in improving parenting and infant outcomes such as: maternal-infant interaction; infant language development; parental attitudes and knowledge (Mercer 2006); paternal competence in parenting, including fostering infant cognitive growth and sensitivity to infant cues (Magill-Evans 2007). Many studies have investigated parental education that transitions from the antenatal period into the postnatal period and were excluded from this review as it is difficult to isolate the effect of postnatal education alone in these studies (e.g., Cupples 2011; Doherty 2006; Petch 2012; Wolfson 1992).

Authors' conclusions

Implications for practice

No recommendations for practice changes can be made at this time, since there exists insufficient evidence to determine the effects of postnatal parental education for optimizing infant general health and care and parent-infant relationships.

Implications for research

Postnatal education occurs on a regular basis in many post-birth settings worldwide. This suggests the need for large, well-designed clinical trials to answer the question of effectiveness on several key aspects of information retention and knowledge gained, together with consequent infant health intermediate outcomes and endpoints.

Common outcome measures across different parent education programs are critical so that the general usefulness of such programs can be determined. Programs should include an assessment of whether they have been successful in teaching participants. Researchers should ensure that outcomes to be measured include those defined as important by both the consumers of this education and those providing new parents with this education.

Conducting such trials will be challenging due to the large amount of information needed by new parents to respond to their infants' needs. Measurement of education received in the 'usual care' arm may be the most difficult to capture but would be key in ensuring clarity of comparisons.

Acknowledgements

Anita Gagnon served as first author on the original review and the protocol. Laurie Barkun served as co-author on the published protocol. Hilary Elkins and Diane Habbouche provided editorial and practical support for the original review. Sharon Grant, Medical Librarian, McGill University verified the search strategies of the original review. Dawn Hooper, Data and Research Services Librarian, University of Prince Edward Island, transferred the original Ovid search strategies to Ebscohost and CSA interfaces and updated additional searches for the previous review.

The National Institute for Health Research (NIHR) is the largest single funder of the Cochrane Pregnancy and Childbirth Group. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR, NHS or the Department of Health.

Data and analyses

Download statistical data

Comparison 1. Education on sleep enhancement versus usual care
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Total infant sleep >= 15 hrs per 24 hrs1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 At 6 weeks11749Risk Ratio (M-H, Fixed, 95% CI)1.72 [1.56, 1.90]
1.2 At 12 weeks11497Risk Ratio (M-H, Fixed, 95% CI)1.73 [1.54, 1.95]
2 Total minutes of infant sleep in 24 hrs (mean diff)3 Mean difference (Fixed, 95% CI)Subtotals only
2.1 At 4 weeks1 Mean difference (Fixed, 95% CI)60.0 [-24.02, 144.02]
2.2 At 6 weeks3 Mean difference (Fixed, 95% CI)62.08 [42.88, 81.29]
2.3 At 8 weeks1 Mean difference (Fixed, 95% CI)-12.0 [-78.58, 54.58]
2.4 At 12 weeks2 Mean difference (Fixed, 95% CI)61.41 [28.08, 94.73]
3 Night-time minutes of infant sleep in 24 hrs (mean diff)3 Mean difference (Fixed, 95% CI)Subtotals only
3.1 At 6 weeks2 Mean difference (Fixed, 95% CI)29.13 [18.53, 39.73]
3.2 At 12 weeks2 Mean difference (Fixed, 95% CI)16.18 [4.41, 27.95]
4 Longest uninterrupted night-time minutes of infant sleep in 24 hrs (mean diff)3 Mean difference (Fixed, 95% CI)Subtotals only
4.1 At 6 weeks2 Mean difference (Fixed, 95% CI)13.74 [-1.11, 28.58]
4.2 At 12 weeks2 Mean difference (Fixed, 95% CI)11.45 [-5.40, 28.30]
5 Day-time minutes of infant sleep in 24 hrs (mean diff)3 Mean difference (Fixed, 95% CI)Subtotals only
5.1 At 6 weeks2 Mean difference (Fixed, 95% CI)39.59 [25.01, 54.17]
5.2 At 12 weeks2 Mean difference (Fixed, 95% CI)9.92 [-1.83, 21.66]
6 Longest uninterrupted day-time minutes of infant sleep in 24 hrs (mean diff)3 Mean difference (Fixed, 95% CI)Subtotals only
6.1 At 6 weeks2 Mean difference (Fixed, 95% CI)5.57 [-2.31, 13.45]
6.2 At 12 weeks2 Mean difference (Fixed, 95% CI)0.60 [-3.89, 5.09]
7 Infant crying time in 24 hrs (mean diff)2 Mean difference (Fixed, 95% CI)Subtotals only
7.1 At 4 weeks1 Mean difference (Fixed, 95% CI)18.0 [-25.63, 61.63]
7.2 At 6 weeks2 Mean difference (Fixed, 95% CI)4.36 [-6.44, 15.16]
7.3 At 8 weeks1 Mean difference (Fixed, 95% CI)42.0 [-6.41, 90.41]
7.4 At 12 weeks2 Mean difference (Fixed, 95% CI)0.55 [-8.38, 9.47]
8 Night-time minutes of infant sleep in 24 hrs1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
8.1 At 12 weeks1316Mean Difference (IV, Fixed, 95% CI)6.0 [-8.21, 20.21]
9 Longest uninterrupted night-time minutes of infant sleep in 24 hrs1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
9.1 At 12 weeks1316Mean Difference (IV, Fixed, 95% CI)-5.0 [-27.66, 17.66]
10 No. of infant night-time sleeping episodes1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
10.1 At 12 weeks1316Mean Difference (IV, Fixed, 95% CI)0.10 [-0.18, 0.38]
11 Day-time minutes of infant sleep in 24 hrs1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
11.1 At 12 weeks1316Mean Difference (IV, Fixed, 95% CI)-5.0 [-19.86, 9.86]
12 Longest uninterrupted day-time minutes of infant sleep in 24 hrs1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
12.1 At 12 weeks1316Mean Difference (IV, Fixed, 95% CI)-5.0 [-11.40, 1.40]
13 No. of infant day-time sleeping episodes1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
13.1 At 12 weeks1316Mean Difference (IV, Fixed, 95% CI)0.10 [-0.12, 0.32]
14 Night-time minutes of infant fussing/crying in 24 hrs1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
14.1 At 12 weeks1316Mean Difference (IV, Fixed, 95% CI)2.0 [-2.24, 6.24]
15 Longest uninterrupted night-time minutes of infant fuss/cry in 24 hrs1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
15.1 At 12 weeks1316Mean Difference (IV, Fixed, 95% CI)0.0 [-2.24, 2.24]
16 No. of infant night-time fussing/crying episodes1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
16.1 At 12 weeks1316Mean Difference (IV, Fixed, 95% CI)0.20 [-0.08, 0.48]
17 Day-time minutes of infant fussing/crying in 24 hrs1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
17.1 At 12 weeks1316Mean Difference (IV, Fixed, 95% CI)3.0 [-4.07, 10.07]
18 Longest uninterrupted day-time minutes of infant fuss/cry in 24 hrs1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
18.1 At 12 weeks1316Mean Difference (IV, Fixed, 95% CI)-1.0 [-3.24, 1.24]
19 No. of infant day-time fussing/crying episodes1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
19.1 At 12 weeks1316Mean Difference (IV, Fixed, 95% CI)0.40 [-0.10, 0.90]
20 Maternal stress score170Mean Difference (IV, Fixed, 95% CI)30.31 [15.20, 45.41]
20.1 At 6 weeks postpartum135Mean Difference (IV, Fixed, 95% CI)23.80 [2.08, 45.52]
20.2 At 12 weeks postpartum135Mean Difference (IV, Fixed, 95% CI)36.40 [15.38, 57.42]
Analysis 1.1.

Comparison 1 Education on sleep enhancement versus usual care, Outcome 1 Total infant sleep >= 15 hrs per 24 hrs.

Analysis 1.2.

Comparison 1 Education on sleep enhancement versus usual care, Outcome 2 Total minutes of infant sleep in 24 hrs (mean diff).

Analysis 1.3.

Comparison 1 Education on sleep enhancement versus usual care, Outcome 3 Night-time minutes of infant sleep in 24 hrs (mean diff).

Analysis 1.4.

Comparison 1 Education on sleep enhancement versus usual care, Outcome 4 Longest uninterrupted night-time minutes of infant sleep in 24 hrs (mean diff).

Analysis 1.5.

Comparison 1 Education on sleep enhancement versus usual care, Outcome 5 Day-time minutes of infant sleep in 24 hrs (mean diff).

Analysis 1.6.

Comparison 1 Education on sleep enhancement versus usual care, Outcome 6 Longest uninterrupted day-time minutes of infant sleep in 24 hrs (mean diff).

Analysis 1.7.

Comparison 1 Education on sleep enhancement versus usual care, Outcome 7 Infant crying time in 24 hrs (mean diff).

Analysis 1.8.

Comparison 1 Education on sleep enhancement versus usual care, Outcome 8 Night-time minutes of infant sleep in 24 hrs.

Analysis 1.9.

Comparison 1 Education on sleep enhancement versus usual care, Outcome 9 Longest uninterrupted night-time minutes of infant sleep in 24 hrs.

Analysis 1.10.

Comparison 1 Education on sleep enhancement versus usual care, Outcome 10 No. of infant night-time sleeping episodes.

Analysis 1.11.

Comparison 1 Education on sleep enhancement versus usual care, Outcome 11 Day-time minutes of infant sleep in 24 hrs.

Analysis 1.12.

Comparison 1 Education on sleep enhancement versus usual care, Outcome 12 Longest uninterrupted day-time minutes of infant sleep in 24 hrs.

Analysis 1.13.

Comparison 1 Education on sleep enhancement versus usual care, Outcome 13 No. of infant day-time sleeping episodes.

Analysis 1.14.

Comparison 1 Education on sleep enhancement versus usual care, Outcome 14 Night-time minutes of infant fussing/crying in 24 hrs.

Analysis 1.15.

Comparison 1 Education on sleep enhancement versus usual care, Outcome 15 Longest uninterrupted night-time minutes of infant fuss/cry in 24 hrs.

Analysis 1.16.

Comparison 1 Education on sleep enhancement versus usual care, Outcome 16 No. of infant night-time fussing/crying episodes.

Analysis 1.17.

Comparison 1 Education on sleep enhancement versus usual care, Outcome 17 Day-time minutes of infant fussing/crying in 24 hrs.

Analysis 1.18.

Comparison 1 Education on sleep enhancement versus usual care, Outcome 18 Longest uninterrupted day-time minutes of infant fuss/cry in 24 hrs.

Analysis 1.19.

Comparison 1 Education on sleep enhancement versus usual care, Outcome 19 No. of infant day-time fussing/crying episodes.

Analysis 1.20.

Comparison 1 Education on sleep enhancement versus usual care, Outcome 20 Maternal stress score.

Comparison 2. Education on infant behaviour versus usual care
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Knowledge of infant behaviour2 Mean Difference (IV, Fixed, 95% CI)Subtotals only
1.1 Maternal at 1-4 days postpartum128Mean Difference (IV, Fixed, 95% CI)4.6 [2.60, 6.60]
1.2 Maternal at 4 weeks postpartum256Mean Difference (IV, Fixed, 95% CI)2.85 [1.78, 3.91]
1.3 Paternal at 1-4 days postpartum128Mean Difference (IV, Fixed, 95% CI)6.5 [4.88, 8.12]
1.4 Paternal at 4 weeks postpartum126Mean Difference (IV, Fixed, 95% CI)3.70 [1.93, 5.47]
2 Child-rearing anxiety161Mean Difference (IV, Fixed, 95% CI)3.70 [-1.33, 8.73]
3 Mother distance161Mean Difference (IV, Fixed, 95% CI)0.20 [-0.11, 0.51]
4 Mutuality161Mean Difference (IV, Fixed, 95% CI)1.10 [-3.07, 5.27]
5 Synchronous co-occurrences during free play - visual136Mean Difference (IV, Fixed, 95% CI)10.10 [5.96, 14.24]
6 Synchronous co-occurrences during free play - vocal136Mean Difference (IV, Fixed, 95% CI)6.73 [3.64, 9.82]
7 Mothers' perception of their infants130Mean Difference (IV, Fixed, 95% CI)0.66 [-8.44, 9.76]
7.1 At 1 month postpartum130Mean Difference (IV, Fixed, 95% CI)0.66 [-8.44, 9.76]
8 Maternal confidence interpreting infant behaviour130Mean Difference (IV, Fixed, 95% CI)3.70 [-1.16, 8.56]
8.1 At 4 weeks postpartum130Mean Difference (IV, Fixed, 95% CI)3.70 [-1.16, 8.56]
Analysis 2.1.

Comparison 2 Education on infant behaviour versus usual care, Outcome 1 Knowledge of infant behaviour.

Analysis 2.2.

Comparison 2 Education on infant behaviour versus usual care, Outcome 2 Child-rearing anxiety.

Analysis 2.3.

Comparison 2 Education on infant behaviour versus usual care, Outcome 3 Mother distance.

Analysis 2.4.

Comparison 2 Education on infant behaviour versus usual care, Outcome 4 Mutuality.

Analysis 2.5.

Comparison 2 Education on infant behaviour versus usual care, Outcome 5 Synchronous co-occurrences during free play - visual.

Analysis 2.6.

Comparison 2 Education on infant behaviour versus usual care, Outcome 6 Synchronous co-occurrences during free play - vocal.

Analysis 2.7.

Comparison 2 Education on infant behaviour versus usual care, Outcome 7 Mothers' perception of their infants.

Analysis 2.8.

Comparison 2 Education on infant behaviour versus usual care, Outcome 8 Maternal confidence interpreting infant behaviour.

Comparison 3. Education on general post-birth infant health or care versus usual care
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Maternal general post-birth knowledge score (mean)1100Mean Difference (IV, Fixed, 95% CI)0.40 [-0.27, 1.07]
2 Maternal general post-birth knowledge score (per cent correct)1100Risk Ratio (M-H, Fixed, 95% CI)1.07 [0.92, 1.23]
3 Infant weight (kg)1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
3.1 At 6 months post-birth1203Mean Difference (IV, Fixed, 95% CI)0.10 [-0.19, 0.39]
4 Infant length (cm)1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
4.1 At 6 months post-birth1202Mean Difference (IV, Fixed, 95% CI)0.30 [-0.88, 1.48]
5 Head circumference (cm)1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
5.1 At 6 months post-birth1203Mean Difference (IV, Fixed, 95% CI)-0.20 [-0.76, 0.36]
6 Appropriate immunization1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
6.1 At 6 months post-birth1202Risk Ratio (M-H, Fixed, 95% CI)1.04 [0.97, 1.11]
7 Knowledge of signs of infant pneumonia1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
7.1 Indrawing1203Risk Ratio (M-H, Fixed, 95% CI)1.21 [0.73, 2.03]
7.2 Tachypnea1203Risk Ratio (M-H, Fixed, 95% CI)1.19 [0.90, 1.58]
8 Knowledge of action to take in the case of infant diarrhoea1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
8.1 Continue breastfeeding1203Risk Ratio (M-H, Fixed, 95% CI)0.99 [0.75, 1.31]
8.2 Give oral rehydration solution1203Risk Ratio (M-H, Fixed, 95% CI)1.00 [0.92, 1.08]
Analysis 3.1.

Comparison 3 Education on general post-birth infant health or care versus usual care, Outcome 1 Maternal general post-birth knowledge score (mean).

Analysis 3.2.

Comparison 3 Education on general post-birth infant health or care versus usual care, Outcome 2 Maternal general post-birth knowledge score (per cent correct).

Analysis 3.3.

Comparison 3 Education on general post-birth infant health or care versus usual care, Outcome 3 Infant weight (kg).

Analysis 3.4.

Comparison 3 Education on general post-birth infant health or care versus usual care, Outcome 4 Infant length (cm).

Analysis 3.5.

Comparison 3 Education on general post-birth infant health or care versus usual care, Outcome 5 Head circumference (cm).

Analysis 3.6.

Comparison 3 Education on general post-birth infant health or care versus usual care, Outcome 6 Appropriate immunization.

Analysis 3.7.

Comparison 3 Education on general post-birth infant health or care versus usual care, Outcome 7 Knowledge of signs of infant pneumonia.

Analysis 3.8.

Comparison 3 Education on general post-birth infant health or care versus usual care, Outcome 8 Knowledge of action to take in the case of infant diarrhoea.

Comparison 4. Education on infant safety versus usual care
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Infant restraint seat fastened by lap belt1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 At hospital discharge130Risk Ratio (M-H, Fixed, 95% CI)21.0 [1.34, 328.86]
1.2 At 4-6 weeks127Risk Ratio (M-H, Fixed, 95% CI)1.24 [0.34, 4.51]
2 Post-hospitalization awareness of tap water burns1604Risk Ratio (M-H, Fixed, 95% CI)1.07 [1.04, 1.11]
3 Greater use of temperature testing1604Risk Ratio (M-H, Fixed, 95% CI)1.76 [1.43, 2.17]
4 Supine infant sleep position2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
4.1 At 1 week161Risk Ratio (M-H, Fixed, 95% CI)1.31 [1.00, 1.72]
4.2 At 6 weeks161Risk Ratio (M-H, Fixed, 95% CI)1.21 [0.85, 1.71]
4.3 At 3 months1191Risk Ratio (M-H, Fixed, 95% CI)1.79 [1.17, 2.72]
4.4 At 6 months1185Risk Ratio (M-H, Fixed, 95% CI)2.18 [1.35, 3.53]
Analysis 4.1.

Comparison 4 Education on infant safety versus usual care, Outcome 1 Infant restraint seat fastened by lap belt.

Analysis 4.2.

Comparison 4 Education on infant safety versus usual care, Outcome 2 Post-hospitalization awareness of tap water burns.

Analysis 4.3.

Comparison 4 Education on infant safety versus usual care, Outcome 3 Greater use of temperature testing.

Analysis 4.4.

Comparison 4 Education on infant safety versus usual care, Outcome 4 Supine infant sleep position.

Appendices

Appendix 1. Search methods used in previous version 2009

Search methods for identification of studies

Electronic searches

We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register by contacting the Trials Search Co-ordinator (30 April 2009).

The Cochrane Pregnancy and Childbirth Group’s Trials Register is maintained by the Trials Search Co-ordinator and contains trials identified from:

  1. quarterly searches of the Cochrane Central Register of Controlled Trials (CENTRAL);

  2. weekly searches of MEDLINE;

  3. handsearches of 30 journals and the proceedings of major conferences;

  4. weekly current awareness alerts for a further 44 journals plus monthly BioMed Central email alerts.

Details of the search strategies for CENTRAL and MEDLINE, the list of handsearched journals and conference proceedings, and the list of journals reviewed via the current awareness service can be found in the ‘Specialized Register’ section within the editorial information about the Cochrane Pregnancy and Childbirth Group.

Trials identified through the searching activities described above are each assigned to a review topic (or topics). The Trials Search Co-ordinator searches the register for each review using the topic list rather than keywords.

In addition, we searched CINAHL (1982 to July 2009), ERIC (1966 to July 2009), HealthSTAR (1966 to July 2009), PsycINFO (1806 to July 2009), Sociological Abstracts (1974 to July 2009), ClinicalTrials.gov (August 2009), Current Controlled Trials (August 2009), Trialscentral.org (August 2009), using the search strategies detailed in below.

We did not apply any language restrictions.

Database: CINAHL: September 2007 to July 2009 (Ebscohost) 

(1)MH postnatal period+ or postnatal

(2)MH parents+ or MH parenting+ or (parent or parents or parenting)

(3)MH breast feeding+ or breastfeeding or breast feeding

(4)MH depression, postpartum+ or postpartum N5 depression

(5)S1 or S2 or S3 or S4

(6)MH postnatal care+ or postnatal care

(7)MH patient education or patient education

(8)MH community health nursing+ or community health nursing

(9)MH parenting education or parenting education or health education

(10)S6 or S7 or S8 or S9

(11)S5 and S10

(12)S11 and (clinical trial or PT clinical trial or controlled trial) 

Database: ERIC: September 2007 to July 2009 (Ebscohost) 

(1)DE birth or birth or DE pregnancy or pregnancy

(2)DE early parenthood or DE obstetrics or DE perinatal influences

(3)(DE adult learning or didactic) or (class or course) or DE teaching methods+ or DE educational research+

(4)DE parenthood education or preparation or (postpartum N5 education) or (postnatal N5 education)

(5)S1or S2

(6)S3 or S4

(7)S5 and S6

(8)S7 and (trial or trials)

Database: HealthSTAR: September 2007 to July 2009 (Ovid)

(1) exp puerperium/ or puerperium.ti,ab,sh. or post partum.ti,ab,sh. or postpartum.ti,ab,sh.

(2) exp parents/ or parenting/ or (parent$ or mother$ or father$).ti,ab,sh.

(3) exp breastfeeding/ or (breastfeeding or breast feeding or breast fed or breastfed).ti,ab,sh.

(4) exp depression, postpartum/ or depression, postpartum.ti,ab,sh.

(5) or/1-4

(6) exp postnatal care/ or postnatal care.ti,ab,sh.

(7) exp health education/ or health education.ti,ab,sh.

(8) preventive health service$.ti,ab,sh.

(9) exp community health nursing/ or community health nurs$.ti,ab,sh.

(10) (educat$ or teach$ or learn$).ti,ab,sh.

(11) or/6-10

(12) 5 and 11

(13) limit 12 to nonmedline

Database: PsycINFO: September 2007 to July 2009 (Ebscohost) 

(1)DE birth+ or DE pregnancy or postpartum or postnatal

(2)DE postpartum depression + or postpartum depression

(3)DE education or preparation

(4)S1 or S2

(5)S3 and S4

(6)S5 and (trial or trials) Limit: Population Group: Human 

Database: Sociological Abstracts: 2007 to July 2009 (CSA Illumina) 

(1)birth or de=birth

(2)pregnancy or exp pregnancy

(3)postpartum or postnatal

(4)#1 or #2 or #3

(5)parent* or exp parent

(6)education or de=education or de=health education

(7)parent training or de=parent training

(8)#6 or #7

(9)#4 and #5 and #8

(10)#9 and (trial or trials) 

Unpublished, planned or ongoing trials databases (all searched August 2009)

Clinical Trials.gov
Current Controlled Trials
Trialscentral.org

(postpartum OR postnatal) AND (parent OR parents OR parenting) 

What's new

DateEventDescription
17 September 2013New citation required but conclusions have not changedFour new studies were included: (Issler 2009; McRury 2010; Paradis 2011; Paul 2011). Two studies originally included (Doherty 2006; Wolfson 1992) were excluded because upon clarification of eligibility criteria, they were deemed not eligible.
31 March 2013New search has been performedSearch updated. Eligibilty criteria reviewed and clarified. Outcomes reviewed and clarified. Methods and Background sections updated.

History

DateEventDescription
11 October 2010AmendedWe have corrected an error in the text. Stremler 2006 did not measure either infant crying or parent confidence. Thank you to Robyn Stremler for bringing this to our attention.
31 August 2009New citation required but conclusions have not changedNew review team updated the review.
31 August 2009New search has been performedSearch updated: one new study included (Golas 1986); nine new studies excluded. One additional meta-analysis conducted and risk of bias tables completed for all included studies. Ten studies excluded in original review due to lack of useable data moved to included studies and tables completed.
31 August 2009AmendedConverted to new review format.

Contributions of authors

For the 2013 update, Janet Bryanton and Cheryl Tatano Beck collaborated to review and assess the literature, enter the data into RevMan 2012, draft all sections of the updated and amended review, and approve the final version of the review. William Montelpare acted as an advisor for the data analysis.

Declarations of interest

None known.

Sources of support

Internal sources

  • McGill University, Canada.

  • McGill University Health Centre - Royal Victoria Hospital Site, Canada.

  • University of Prince Edward Island, Canada.

External sources

  • Le Fonds de la recherche en santé du Québec (FRSQ), Canada.

  • Canadian Cochrane Network - McGill University Site, Canada.

  • Groupe de recherche interuniversitaire en soins infirmiers de Montreal (GRISIM), Canada.

Differences between protocol and review

We have:

  • changed the title from 'Postnatal parental education for improving family health' to 'Postnatal parental education for optimizing infant general health and parent-infant relationships', as we believe this reflects the scope of our review more accurately;

  • updated the Methods section in line with the Cochrane Pregnancy and Childbirth Group's guidelines;

  • reviewed and clarified outcomes. Maternal/paternal infant care competence was deleted because it overlapped infant preventive care and maternal/paternal care confidence. It was replaced by maternal/paternal stress/anxiety;

  • presented all the results for dichotomous data as risk ratios (RR) with 95% confidence intervals - in previous versions of this review a mix of risk ratios (RR) and odds ratios(OR) had been used.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Anderson 1981

MethodsRandomization to 3 groups: 1 control and 2 intervention. Method of randomization not stated. Blinding of outcome assessors. Single-centre trial. 
ParticipantsIncluded 30 mothers and newborns. Inclusion criteria were: primiparas having uncomplicated pregnancies, labours, and births, local or regional anaesthesia, full term, healthy, female newborns, no post-birth complications. All breastfeeding. Trial conducted in a 500-bed community hospital likely in Chicago, Illinois, USA.
InterventionsGroup 1 (Control) received no instruction. Brazelton Assessment performed in nursery with mom not present, no feedback to moms, offered a class on infant furnishings during postpartum hospital stay. Group 2 (Explanation only) Brazelton Assessment performed in the nursery without mom present. Following assessment the investigator met with the mother in her postpartum room and explained the assessment done, her infant’s performance and positive aspects of performance stressed. Group 3 (Demonstration and Explanation) Investigator met with mother in her room, performed the Brazelton Assessment in the mother’s presence and gave an explanation of the assessment throughout. 10 dyads randomized per group.
OutcomesAn independent assessor (graduate student) assessed mother-infant dyads observed during a feeding at 24-48 hours (pre-test) and 10 to 12 days postpartum (post-test) (not clear where data were collected at 10 days). Measured Maternal Reciprocity (13 items), Infant Reciprocity (5 items) and Maternal-Infant Interaction (3 items). Items scored 1 to 5 with 1 representing low reciprocity and 5 representing high reciprocity. 
NotesSmall sample, no power analysis noted. No useable data.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskMethod of randomization not stated.
Allocation concealment (selection bias)Unclear riskAllocation concealment not discussed.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo blinding discussed.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBlinding of outcome assessor.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo losses discussed.
Selective reporting (reporting bias)High riskFindings reported but no data on maternal-infant interaction. Infant reciprocity data incomplete for Group 3.
Other biasLow riskGroups equivalent at baseline.

Bolam 1998

MethodsBlock randomization to 4 groups: 3 intervention and 1 control. Blinding of outcome assessors (different assessors at 3 and 6 months). Single-centre trial.
ParticipantsIncluded 540 Nepalese participants, all pregnant women admitted to Prasute Griha Hospital. Exclusion criteria were: women who had stillbirths or discharged from hospital before randomization occurred.
InterventionsIncluded 1-on-1 teaching for mothers in treatment groups. None for control (Group A - teaching at birth and 3 months, Group B - birth only, Group C - 3 months only, Group D - none) (n = 135 women randomized to each group). Intervention occurred in hospital and at home and included topics such as breastfeeding, treatment of diarrhoea, recognition of and response to upper respiratory tract infections, immunization, and family planning.
OutcomesMothers' knowledge of pneumonia, indrawing, tachypnoea; knowledge of diarrhoea; give rehydration solution; immunized infant. Infants' weight gain, length, and head circumference. Comparisons presented in analyses are for Group B vs Group D as only these groups met review inclusion criteria of 2 months post-birth.
NotesMay have included teens and mothers of NICU babies. Power analysis on all outcomes.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskBlock randomization using blocks of 20, random ordering of numbers from 0 to 19. Numbers 0-4, 5-9, 10-14, and 15-19 were assigned to groups A to D respectively.
Allocation concealment (selection bias)Low riskSequentially numbered, sealed, opaque envelopes. Generator of assignment was not involved in execution of allocation.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo blinding discussed.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskSingle blinding of outcome assessors (different assessors at 3 and 6 months).
Incomplete outcome data (attrition bias)
All outcomes
High riskReported losses for all groups at 3 and 6 months due to stillbirth, infant death, and loss to follow-up. Total losses Group A (30%), Group B (22%) Group C (29%), Group D (27%). No imbalance across outcomes. No intention to treat. Greater than 20% attrition.
Selective reporting (reporting bias)Low riskAll outcomes reported.
Other biasLow riskGroups equivalent at baseline except 15% difference in illiteracy between groups B and C.

Christophersen 1982

MethodsMothers were selected sequentially from the obstetrics ward and randomly assigned by coin toss, in pairs to either the restraint seat group or usual care. There was no blinding of patients, caregivers, or outcome assessors. Single-centre trial.
ParticipantsIncluded 30 mothers who gave birth at Shawnee Mission Medical Center, a private non-profit hospital in suburban Kansas City, USA to a single live infant with baby's doctor practising within a 10-mile radius.
InterventionsIntervention (restraint seat): mothers (n = 15) were approached in their rooms prior to discharge by trained staff and offered a demonstration of the proper placement of the infant in the infant restraint seat, how to carry the seat with the infant in it, and the correct restraining of the seat with the automobile lap belt. They also placed the infant in the seat and securely in the car. Control group mothers (n = 15) were discharged in the usual manner.
OutcomesCorrect use of infant restraint seat at discharge and at 4 to 6 week follow-up.
NotesMothers were not asked to participate in the study; however their obstetricians, paediatricians, and family practitioners were asked for informed consent to observe their patients. The study was reviewed by the Medical Center Committee on human subjects. Interobserver reliability 100% at both times. Although education was given in the experimental group, the intervention included placing the newborn correctly in the car. Thus the observed outcome was either the result of the parents physically removing the infant or the staff member putting the infant in correctly.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomly assigned by coin toss to "restraint seat" or "no restraint seat" group.
Allocation concealment (selection bias)Unclear riskNot discussed.
Blinding of participants and personnel (performance bias)
All outcomes
Low riskParticipants were not aware they were in a study so they were essentially blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo blinding discussed.
Incomplete outcome data (attrition bias)
All outcomes
Low riskAt discharge no loss. At 4 to 6 weeks, .5% loss in treatment (n = 1) and 1% in control (n = 2). No intention-to-treat.
Selective reporting (reporting bias)Low riskMain outcome reported for both groups at both times.
Other biasHigh riskNo baseline data collected so unclear if groups equivalent at baseline.

Flagler 1988

MethodsRandomization to intervention and control group. Method of randomization not stated. No blinding. Likely a single-centre trial.
ParticipantsIncluded 74 American participants. Inclusion criteria were: vaginal birth, primipara, 20-30 years of age, living with father, normal full-term infant, and uncomplicated postpartum.Trial conducted in San Francisco, CA, USA.
InterventionsA 20-minute Brazelton assessment, individual demonstration of normal newborn behaviour with mother on second or third day postpartum in mother's room. Nothing stated regarding control group. The article did not state the number of participants randomized to each group (at analysis n = 31 in intervention n = 30 in control).
OutcomesIncluded maternal role competence as measured by: (1) the mother's perception of herself as a mother as compared against an ideal mother (15 items on a 7-point scale), with smaller distances between the 2 indicating greater role competence; (2) mutuality - the mother's ability to perceive her infant's cues, using the 10-item Issue One Subscale of the Maternal Attitude Scale; and (3) maternal anxiety related to child-rearing using the 14-item MAS subscale - a higher score reflects less anxiety. Data collection occurred at baseline and in the home 4 to 6 weeks' postpartum.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskMethod of randomization not stated.
Allocation concealment (selection bias)Unclear riskNot discussed.
Blinding of participants and personnel (performance bias)
All outcomes
High riskNo blinding.
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNumbers not given for initial randomization to groups. 13 lost to follow-up (18%) but not stated which group. No intention-to-treat.
Selective reporting (reporting bias)Low riskReported on all outcomes
Other biasLow riskGroups at baseline comparable except for gender of infant.

Gibson 1995

MethodsRandomization done by having mother select a number from a box that contained numbered wooden squares. Mothers selecting even numbered squares were placed in the intervention groups and those selecting odd-numbered squares were placed in the control group. No blinding evident. Single-centre trial.
ParticipantsIncluded 40 mothers on the postpartum unit of a metropolitan hospital in Arlington, Texas, USA. Inclusion criteria were not stated but all newborns were full term and were in the normal newborn nursery. 
InterventionsThe control group (n = 20) received 20 minutes of education related to first year infant feeding practices. The intervention group (n = 20) received the same 20 minutes of education as well as an additional 10 minutes of teaching with the same information  in the form of a video but condensed (50% over learning beyond the mastery level). Teaching was done in group format on the postpartum unit. Did not state number of days postpartum. 4 lost to follow-up at 2 weeks.
OutcomesIncluded maternal knowledge of infant feeding practices measured by the Infant Feeding Questionnaire which contained 16 multiple choice and 8 true and false questions. Pretest given to all mothers. If scored less than 95% (less than mastery), they were given correct answers and brief explanation. Then they answered questions they missed and process repeated until they had 95% or above. Post-test at 2 weeks during a visit to paediatrician or home visit.
NotesContent validity and internal consistency of instrument satisfactory. Ratings done by 2 nurses on similarity between verbal directions and film (4.6 and 4.8 on a scale of 5). No useable data.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomization done by having mother select a number from a box that contained numbered wooden squares.
Allocation concealment (selection bias)High riskNo allocation concealment.
Blinding of participants and personnel (performance bias)
All outcomes
High riskNo blinding evident.
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding evident.
Incomplete outcome data (attrition bias)
All outcomes
Low risk4 lost to follow-up at 2 weeks were not included in analysis.
Selective reporting (reporting bias)Low riskOutcomes reported but data not useable as only reported t-test and P values.
Other biasLow riskStated extraneous variables controlled by randomization but no baseline characteristics reported.

Goetter 2005

MethodsRandomization to intervention and control group. Method of randomization not stated and no blinding occurred. Single-centre trial.
ParticipantsIncluded 61 American participants. Inclusion criteria were: primiparas, 18-35, English-speaking. Exclusion criteria were: NICU infants and women who knew researcher. Trial conducted in a mountain community hospital, possibly Wyoming.
InterventionsIntervention (n = 32) included positioning for SIDS prevention, individual instruction with mother in hospital postpartum, explanation and demonstration of positioning, and how to maintain position, definition and causes of SIDS. Control (n = 29) received usual care (inconsistent individual or group teaching SIDS might or might not be mentioned).
OutcomesIncluded first week positioning (supine/not supine). Also, at 6 weeks, current position, last night's position, and today's nap position.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskMethod of randomization not stated.
Allocation concealment (selection bias)Unclear riskNot discussed.
Blinding of participants and personnel (performance bias)
All outcomes
High riskNo blinding.
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding.
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo losses to follow-up.
Selective reporting (reporting bias)Low riskAll outcomes reported.
Other biasUnclear riskGroups not equivalent at baseline. Intervention group was older and included more Caucasians than the control group.

Golas 1986

MethodsRandomization to intervention, contrast, and control groups. Method of randomization not described. Groups equivalent at baseline. No blinding. Single-centre trial.
ParticipantsIncluded 54 mothers and newborns. Inclusion criteria were: primiparas, uncomplicated births, newborns received examinations by private paediatrician group practice, term infants, no congenital anomalies  or medical complications in first 2 weeks of life. Exclusion criterion was: multiple births. Mothers were well educated, adults, married, white, middle-class Americans from Baltimore, MD, USA.
Interventions19 mother-infant dyads randomized to intervention: n = 19 to contrast and n = 16 to control group. Intervention included individual 2-hour session by nurse practitioner with each mother-infant dyad within 5 days of newborn being 2 weeks old. Setting: examination room of paediatrician’s office. Teaching plan with specific goals but delivered in a flexible order based on infant behaviour and mother’s responses and questions. (1) viewed a 25-minute film (The Amazing Newborn); (2) oral and visual presentation of different states of infant behaviour and appropriate maternal response; (3) demonstration of selected items from BNBAS and return demonstration by mothers, individually based on newborn. Control received no contact with paediatric nurse practitioner at 2 weeks. Contrast received no contact with nurse practitioner at 2 weeks. Completed Newborn Information Checklist at 2 weeks. Teaching provided to control and contrast mothers following study.
OutcomesMeasurements taken at 4 weeks postpartum lasting 20-25 minutes. Included (1) maternal knowledge of newborn characteristics and capabilities from birth to 4 weeks: consolability; interpretation of physical cues, crying, visual auditory responses. 20 items worth 1 point. Total score 0-20; (2) maternal confidence in interpreting infant behaviour. 12 items rated 1-5. Total score 12-60; (3) maternal satisfaction with teaching intervention-mean response (only intervention group). 
NotesSmall sample. No mention of power analysis.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskMethod of randomization not discussed.
Allocation concealment (selection bias)Unclear riskNot discussed.
Blinding of participants and personnel (performance bias)
All outcomes
High riskNo blinding.
Blinding of outcome assessment (detection bias)
All outcomes
High riskResearcher conducted intervention and collected data.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskOverall a 14.8% loss (10.5% intervention; 15.8% contrast; 18.8% control). 5 withdrew after randomization (n = 2 intervention, n = 1 contrast, n = 2 control), and 3 were excluded from analysis because 1 had twins and 2 were enrolled in a similar class (n = 2 contrast and n = 1 control). Did not use intention-to-treat.
Selective reporting (reporting bias)Low riskAll outcomes reported.
Other biasLow riskChi2 analysis to rule out confounding by telephone information that was included in the teaching intervention given to mothers across groups. No significant difference in occurrence of calls to office between groups.  Groups were comparable at baseline.

Hall 1980

MethodsRandomization to intervention and control group. Method of randomization not stated and no blinding was described. Single-centre trial.
ParticipantsIncluded 30 participants recruited in the US, possibly in South Carolina. Inclusion criteria were: 18-30 years, primiparas, married, no chronic disease, an uncomplicated pregnancy, vaginal birth, full-term, no complications during birth and postpartum.
InterventionsIncluded individual teaching for mothers at home in 1 session 2 to 4 days postpartum. They were assessed individually based on learning needs, taught normal newborn behaviour, crying, feeding, spitting up, elimination, and predictability. 15 each randomized to intervention and control group. No mention if control received usual care.
OutcomesData collected at 1 month and included perception of infant and mean scores on neonatal perception. Results are presented as differences between the average baby and the mother's baby; lower values indicate more positive perceptions.
NotesSample chosen deliberately. No power analysis mentioned.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskMethod of randomization not discussed.
Allocation concealment (selection bias)Unclear riskNot discussed.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo blinding discussed.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo blinding discussed.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo mention of losses. Sample sizes at analysis were not given.
Selective reporting (reporting bias)Low riskAll outcomes reported.
Other biasLow riskGroups similar at baseline.

Issler 2009

MethodsBlock randomization Monday to Friday (excluded weekends to prevent contamination between groups). Blocks of 4 consecutive weeks at a time. Outcome assessor blinded. Single-centre trial.
ParticipantsIncluded 228 mother-infant pairs "living in a previously selected area of Porto Alegre" from September 2005 to September 2006. Pairs were excluded if mothers had a "severe physical handicap or mental health problems" such as "profound depression or overt schizophrenia". Study took place on the maternity ward of a large teaching hospital in a large city in Brazil.
InterventionsIntervention: 112 mothers received a 1-on-1 oral orientation and demonstration using a baby doll model regarding sleep position. They were also given a folder with information about infant sleep positioning and received the routine oral orientation from hospital personnel. The education occurred in the mother's hospital room. Control: 116 mothers received usual care which included routine oral orientation from hospital personnel.
OutcomesInfant sleep position at 3 and 6 months observed by an interviewer in the home or demonstrated by the mother if infant was awake during visit.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskTossed a coin to randomize in blocks of 4 consecutive weeks. Women giving birth on weekends were not included but this should not result in a selection bias.
Allocation concealment (selection bias)Low riskAll women who gave birth during the week assigned by randomization were eligible. All received the same condition for that week with no recruitment to minimize possible contamination effects.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot clear if women were blinded to study hypotheses. Otherwise clinicians nor mothers were blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessors were blinded to group assignment. Once initial data were collected, group assignment was sealed in an envelope and not opened until the study was completed.
Incomplete outcome data (attrition bias)
All outcomes
High riskFollowing randomization, loss to follow-up in intervention group n = 21 (2 refused to participate, 10 moved to another town, 9 were not found at the stated address) and n = 16 in the control group (1 refused to participate, 8 moved to another town, 7 were not found at the stated address). The control group lost another 6 by 6 months. Attrition was comparable in both groups. (Intervention = 19% and control = 14% at 3 months and 19% for both at 6 months). No intention-to-treat analysis. At 3 months 91 were analyzed in the intervention group and 100 in the control and at 6 months 91 and 94 were analyzed respectively.
Selective reporting (reporting bias)Low risk2 outcomes reported.
Other biasLow riskBaseline equivalence except for marital status. In intervention group more women were married or living with a partner. This was not associated with sleeping position in bivariate analysis.

Jones 1977

MethodsRandomization to 4 groups: 3 intervention and 1 control group. Method of randomization not stated. Experimenter and outcome assessor blinded. No other blinding mentioned. Single-centre trial.
ParticipantsIncluded 40 mothers from Oklahoma, USA. Inclusion criteria were: well, primiparous women of a clinic population of 1 hospital who had a vaginal birth and planned to keep their infants; well, term infants without evidence of IUGR or anomalies, with a 1-minute Apgar greater than 4 and a 5-minute Apgar greater than 7. Exclusion criterion was: multiple births.
InterventionsIntervention and data collection occurred on the postpartum unit of 1 hospital. 10 mothers received “Additional Information (AI)” by the neonatologist within 24 hours post-birth. They were informed about sensory capabilities of newborns and encouraged to be aware of their infant’s capabilities. 10 mothers received “Additional Contact (AC)”. They were instructed by a nurse within 24 hours of birth to stroke their nude infants for 10 minutes, dress and hold or rock their infants for 5 minutes after 4 daily feedings. Benefits of skin to skin also given. 10 mothers received “Additional Contact and Additional Information (AI-AC). 10 control mothers received traditional contact which was a glimpse of the infant after birth, brief contact at 6 to 12 hours and visits of 20 to 30 minutes every 4 hours for feeding. Data collection occurred before discharge in the nursery on days 3 to 6.
OutcomesMaternal behaviours were observed from video-taped sessions of mothers watching their infants during the discharge exam (distance from infant, questions about care, questions about condition, contact with infant, behavioural responsiveness, verbal responsiveness to infant, verbal responsiveness to physician, distress of infant) and during a feeding (enface position, lateral trunk contact, fondling of infant, vocalizations). Behaviours were given a total score representing the presence of the behaviour at any time within a 30-second film clip summed over a series of 5 film clips. Left Sided Preference to Hold Infant presented from midline also observed. 
NotesInter-rater reliability 70% to 100% on 10 observations with an average of 91.6%. 10% refusal rate. Teenagers included in sample. No useable data.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskMethod of randomization not stated.
Allocation concealment (selection bias)Unclear riskNot discussed.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskExperimenter blinded, otherwise not discussed.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessor blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low risk3 moms discharged before data collected were replaced by next eligible subject assigned to condition.
Selective reporting (reporting bias)High riskAll outcomes discussed but ANOVA tables for each outcome present only mean square and f ratio and data not useable.
Other biasLow riskGroups equivalent at baseline.

Keefe 2005

MethodsRandomized by project co-ordinator using central computer randomization. 3 groups: intervention, control, and post-test only group. Post-test only group not randomized (used to compare to control on outcome data to illustrate any changes due to attention from evaluation team or developmental changes alone). Evaluation team blinded, separate from intervention team. 2 centres.
ParticipantsIncluded 180 newborns and their parents. Inclusion criteria were: healthy, full-term, low risk infants between 2 to 6 weeks of age, living within a 2-hour radius of the city, and having unexplained crying more than 2.5 hours per day over the past week. Conducted in Charleston, South Carolina and Denver, Colorado, USA.
InterventionsControl group received routine care (not described). 121 in intervention and control. Doesn’t state number per group except 43 in non-randomized post-test only. Intervention parents received REST program. Intervention nurses formed specific recommendations and care plans for each infant. 4 home visits, 1 per week. Both parents received individual instruction, demonstration, written material, video in the home over the 4 visits. 16 lost to follow-up, not included in analysis.
OutcomesIncluded hours of infant crying using a crying log and infant fussiness using Fussiness Rating Scale (Likert-type scale). Collected at baseline, 4 weeks and 8 weeks.
NotesPower analysis done. No useable data.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomized by project coordinator using central computer randomization.
Allocation concealment (selection bias)Low riskAdequate concealment.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo blinding discussed.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskEvaluation team blinded, separate from intervention team.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk16 withdrew or were lost to follow-up after randomization not included in analysis. Not explicit about numbers per group and losses per group not clear. States no differences between those who left and completed. No intention-to-treat.
Selective reporting (reporting bias)Unclear riskAll outcomes reported but not able to use data as unable to determine numbers per group and only P values or percentages given.
Other biasLow riskNo baseline data given but states groups are comparable on race, gender, birth outcome, parental characteristics.

Liptak 1983

MethodsInfants randomly assigned following Brazelton Assessment to 1 intervention and 2 control groups. Method of randomization not stated. Blinding of outcome assessor. Single-centre trial.
ParticipantsIncluded 75 mother-infant dyads. Inclusion criteria were: full term, first-born, healthy, white newborns of English speaking, middle class parents from Strong Memorial Hospital, Rochester, New York, USA.
InterventionsControl Group 1 infants received usual care. Physical exams were performed in the absence of parents. Mothers were visited by 1 of the researchers every day and any concerns raised by the mothers were addressed. Routine anticipatory guidance given. Control Group 2 infants received the same as Group 1 but in addition received complete physical exams in front of the mothers on the morning of discharge from hospital as well as a discussion of normal findings. This group was selected to control for the Hawthorne effect of an investigator intervention. Intervention Group 3 infants received the same care as those in Control Group 1 but also had parts of the Brazelton Neonatal Assessment Scale demonstrated to their mothers on the morning of discharge approximately 30 minutes following a feeding. A 20-minute semi-structured discussion, modified for the individuality of each infant, was held with the mother. Number randomized to each group not given; however it may have been 25 per group. 3 lost to follow-up; 2 before the first home visit and 1 after. Did not report on which group losses occurred.
OutcomesOutcomes measured at 1 and 3 months postpartum on home visits. Included observations and measurement of (1) gross physical contact, (2) feeding additional food, (3) positive contact, (4) overall Ainsworth rating, (5) mothers asking developmentally related questions, (6) mothers continuing to seek medical advice as well as self-reports of degree of bother, infant temperament. Following feeding, 35- and 45-minute observations during play. Observer recorded infant and maternal behaviour every 15 seconds using a behaviour checklist. After leaving home, observers rated mother-infant interactions using 21 9-point interaction scales by Ainsworth. At 1 month completed Broussard Perception Inventory and modified Degree of Bother Scale, and Carey Infant Questionnaire at 3 months. 
NotesPower analysis done. Inter-rater reliabilities ranged from 83% to 96%. No useable data.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo method of randomization discussed.
Allocation concealment (selection bias)Unclear riskNot discussed.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo blinding discussed.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBlinding of outcome assessor.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk3 lost to follow-up but do not state to which group. No intention-to-treat.
Selective reporting (reporting bias)High riskAll outcomes addressed but they do not give the number randomized per group. Not able to use data because of this as only percentages and P values reported.
Other biasUnclear riskDemographic baseline characteristics appear comparable although not discussed.

McRury 2010

MethodsBasic randomized design. Mother-infant dyads assigned using a random numbers table. Outcome assessor blinded. Single-centre trial.
ParticipantsIncluded 51 mother-infant dyads. Infants were singletons, 37-41 weeks' gestation, and admitted to the normal newborn nursery. Mothers were required to have resources to view VHS tape. Exclusion criteria: mothers who did not speak English or were unable to fill out a diary. Conducted in Columbus, Ohio in a large community hospital.
InterventionsIntervention: 27 mothers were given a 30-minute video to view in hospital and then take home to view as well. Specific instructions about 5 steps to use to soothe infant during crying. Control: 24 mothers watched a 30-minute video "Begin with Love" that was offered on the newborn channel with standard anticipatory guidance about infant needs and care. Both groups received a lightweight blanket for swaddling.
OutcomesMothers documented sleep and crying in a diary 3 days per week during the 1st, 4th, 6th, 8th, and 12th week. Diaries were analyzed as 1) mean hours of total infant crying per day (time fussing, crying, inconsolable was calculated for each day; the mean of the daily sums at each time was calculated) and 2) mean daily total sleep time was calculated similarly to crying time. "Diary data that had more than 3 hours not recorded or recorded as 'can't remember' were excluded from the analysis". 3) Mother's level of stress was measured by the Parenting Stress Index at 6 and 12 weeks. "Total stress scores can range from 131 to 320 (less stress to more), with a score of 222 being the 50th percentile".
Notes1408 flyers distributed and 51 recruited. Nothing mentioned re validity or reliability of instrument but stated that it was "scored according to the manual". Sample small and under powered. Needed 42 per group to "detect a minimally intense intervention to reduce crying time by 40%".
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom numbers table used.
Allocation concealment (selection bias)Unclear riskNot discussed.
Blinding of participants and personnel (performance bias)
All outcomes
Low riskMothers blinded. Given an unmarked jacket on video so did not know which video they received.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskResearch assistant was blinded during baseline data collection but not during follow-up data collection as intervention fidelity was assessed.
Incomplete outcome data (attrition bias)
All outcomes
High risk9 pairs were lost to the intervention group (33%) and 7 to the control group (29%). Lower levels of education in those who left but about the same number in each group. No intention-to-treat. 18 analyzed in intervention group and 17 in control. Some diaries were incomplete.
Selective reporting (reporting bias)Low riskAppears to have provided data on all outcomes.
Other biasLow riskBoth groups equivalent at baseline.

Moore 1987

MethodsRandomization to intervention and control group. Method of randomization not stated. No mention of blinding. May have been a multi-centre trial.
ParticipantsIncluded 159 mothers who gave birth at the University of Texas Medical Branch Hospitals, Galveston Texas, USA. Inclusion criteria were: mothers who had a cesarean birth, were literate, spoke English, 17 years of age or older and singleton infants born after 37 weeks. Also, mother had to be able to hold and feed infant in her room.
InterventionsOn the third postpartum day, mothers in intervention group saw a video focusing on the manner in which infants from birth to 9 months exhibit multi-sensory capabilities for communication and how with interaction these capabilities can be enhanced. No mention if intervention was individual or group. No description of control group given. Number randomized to each group not stated.
OutcomesMaternal behaviour was assessed on the fourth postpartum day during a feeding. Maternal attachment behaviour assessment total and composite factor scores (e.g., maternal attentiveness, tactile response, body contact) were used. 
NotesNo useable data.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo method of randomization discussed.
Allocation concealment (selection bias)Unclear riskNot discussed.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo blinding discussed.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo blinding discussed.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo mention of losses. Number per group not given.
Selective reporting (reporting bias)High riskAbstract only. No data presented.
Other biasUnclear riskNo baseline equivalence discussed.

Myers 1982

MethodsRandomization to 3 groups: (1) mother intervention, none for father, (2) father intervention, none for mother, (3) control was made post recruitment by the throw of a die. Single-centre trial.
ParticipantsIncluded 42 middle-class married couples in the US who had just had their first baby. No inclusion/exclusion criteria were specified.
InterventionsThe 2 intervention groups (n = 14 fathers in 1 group and n = 14 mothers in another) were taught individually how to administer most of the items of the Brazelton exam. Throughout the session, the experimenter gave information about infant development related to the infant's performance. The experimenter aimed at being supportive. Information learned was encouraged to be given to the other partner and to be used at home. The intervention was given after second day post-birth but before departure for home at day 4. Sessions were held in mother's room for the mothers and in a small room near the nursery for the fathers. Sessions lasted 45-60 minutes.
OutcomesIncluded (1) knowledge of infant behaviour as measured by a set of 15 multiple choice factual questions related to infants' physical capacities, including reflexes and senses (higher scores out of a maximum of 15 indicate more knowledge); (2) feelings of confidence as a caregiver; (3) feeling of affection and satisfaction with the infant; (4) behaviour with the infant. Measures were made greater than 6 hours after intervention.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom assignment by the throw of a die.
Allocation concealment (selection bias)Unclear riskNot discussed.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo blinding discussed.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo blinding discussed.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot discussed.
Selective reporting (reporting bias)Low riskAll outcomes reported.
Other biasUnclear riskAcceptance rates post randomization were about 66% overall but greater (no % given) in father intervention and control groups.Timing of outcome assessment an issue, since some were tested as soon as 6 hours after the intervention but no data are presented by group on this issue. No data on group comparisons at baseline were given.

Paradis 2011

MethodsBlock randomization using random numbers table to 1 intervention and 1 control group. Randomization occurred by week in blocks of 8 weeks to account for seasonal variation in birth rate. Blinding of outcome assessors. Single-centre trial.
ParticipantsIncluded 126 mothers and 11 fathers who were: 18 years of age or older, able to read and speak English, had access to a working telephone, and whose infant was less than 1 month old. Exclusion criteria: parents of premature or medically complex infants. Trial conducted in Rochester, New York, USA in a large hospital with a hospital-based primary care paediatric practice.
InterventionsIntervention: a media-based learning intervention of a 15 minute locally produced DVD was given to 70 parents during the baby's first visit to the paediatrician's office. The video depicted basic aspects of newborn care that were endorsed by the American Academy of Pediatrics and Brighter Futures guidelines. Content included: normal newborn breathing patterns, bathing, feeding, safe sleep, dealing with crying, promoting development. A staff member started the DVD in the exam room and it was stopped if it was still running when the provider came in. The DVD was then given to parent to take home. Control: 67 parents received an enhanced standard of care. They were given a packet of written handouts (written at the 4th grade reading level) that were already available at the clinic and covered similar but not identical material to the DVD. Parents were given the packet during the first clinic visit.
OutcomesParent: 1) knowledge of infant development using 14 questions from a 58-item Knowledge of Infant Development Inventory (chose questions pertaining most to newborns, answered agree, disagree, not sure); 2) self-efficacy using 20 items from a 52 item Infant Care Survey (rated on a 5-point scale from 1 (little confidence) to 5 (quite a lot of confidence); 3) problem solving competence using the How I Deal with Problem Regarding Care of My Baby Questionnaire (rated from 1 (never) to 9 (always) for a maximum score of 90). 3 scales administered at baseline and at 2 weeks post visit by telephone. Did not separate out mothers and fathers. Infant: health care utilization for infant assessed by chart review at 2 months. Utilization included: parent initiated clinic visits, phone calls, emergency department visits.
NotesNo validity or reliability information was given on the 2 adapted scales. Stated the third scale was validated but no further information. No useable data. Attempted to contact author with no response.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Randomization occurred by week (rather than by subject) to simplify administration of the intervention for the nursing staff". "Used a random-numbers table to generate the assignment of weeks to treatment or control in blocks of 8 to account for seasonal variations in birthrate".
Allocation concealment (selection bias)Low risk"At the beginning of each week, the principal investigator informed the nursing staff of whether" it was a treatment or control week. It is unlikely that a parent would not come for a visit knowing it was a control week or a treatment week.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot clear if participants were blinded. Personnal were not blinded. Recruiter was blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Low risk"Outcomes were assessed by research associates who were blinded to group allocation".
Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss of 6 participants, 3 per group: 1 refused and 2 lost to follow-up per group. Intervention = 4.3% loss and control = 4.4% loss. Performed an intention-to-treat analysis.
Selective reporting (reporting bias)Low riskDescribed findings for primary and secondary outcomes.No useable data, as data are reported in pre- and post-mean within-group differences.
Other biasUnclear riskIntervention group had more mothers and infants of Hispanic ethnicity and control group had more babies born outside hospital and being exclusively breastfed. Control group had better knowledge of infant development. Researchers adjusted for these baseline differences in analyses.

Paul 2011

MethodsStratified, randomized factorial 2X2 design. Mother baby dyad unit of randomization. Randomization method not described. Single-centre trial. It appears no blinding was used.
ParticipantsFull study included 160 mother baby dyads. Focus for this review is 80 mother baby dyads: 39 in intervention and 41 in control. Infants were included if they were singleton, 34 weeks' gestation or greater, without morbidities that would affect sleeping or feeding. Mothers were English speaking primiparas, who intended to breastfeed and follow-up care with a university affiliated primary care provider. Pairs were excluded if either newborn or mother had a hospital stay 7days or more and if mothers had a major pre-existing morbidity or condition that would affect postpartum care or study participation such as cancer, MS, or lupus. Study took place in Hershey, Pennsylvania, USA.
InterventionsThe "Soothe/Sleep" intervention was delivered by nurses during the first home visit at 2 to 3 weeks. Intervention included 1-on-1 verbal information, an instructional handout, and a commercially prepared video. Parents were taught "alternative strategies to feeding as an indiscriminate first response to infant distress" in an attempt to have parents understand the difference between crying from hunger versus other causes of crying. The video included strategies to calm and soothe the infant during the day and night when it was time for sleep. They also received a standard infant parenting book. The control parents received the standard infant parenting book. All parents had their questions answered.
OutcomesIncluded: infant weight-for-length percentile at 1 year; total daily crying and fussing; total daily sleep; total nocturnal sleep from 9pm to 6 am; timing and content of feedings measured by 96 hour diary cards at 3, 4, 8, 16, 24, 36, and 48 weeks post-birth. These were detailed at 15-minute intervals. Relative percentage of breast milk versus formula was documented using a visual analogue scale.
NotesMay have included infants in NICU. No useable data. Contacted author who chose not to provide data.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot addressed other than being stratified based on maternal prepregnancy BMI < 25 or >= 25.
Allocation concealment (selection bias)Unclear riskNot discussed.
Blinding of participants and personnel (performance bias)
All outcomes
High riskAppears no blinding was used. Nurses providing the intervention could not be blinded.
Blinding of outcome assessment (detection bias)
All outcomes
High riskNurses measuring infants were not blinded.
Incomplete outcome data (attrition bias)
All outcomes
High riskGreater than 20% loss to follow-up in both groups. Losses equal across groups. Mothers not completing were significantly younger, less educated, single, non-white, and medicaid insured. No intention-to-treat for those who were randomized but did not receive the intervention. Some for non-completers who had growth data from second home visit.
Selective reporting (reporting bias)Low riskAppears to have reported on all outcomes but data not useable.
Other biasLow riskBaseline equivalence across all groups.

Petrowski 1981

MethodsRandomization to 4 groups: 3 intervention and 1 control. No method of randomization stated. No blinding noted. 2 hospital sites.
ParticipantsIncluded 56 mothers. Inclusion criteria were: primiparas who were staff patients of 2 inner-city hospital clinics in Washington, DC, USA, were educated in the USA, and who gave birth to healthy, normal newborns not less than 5 pounds.
InterventionsGroup 1 (n = 10) received the Instructional Package Form 1 in the last trimester of pregnancy. (Instructional Package included 4 cassette recordings: Care of the Umbilical Cord and Navel, Burping or Bubbling a Baby, Perineal Care, and Rest, Activity, and Exercise. Each tape accompanied by 13 pictures. 2 alternate forms). This group was also re-instructed postpartum in hospital using Form 2. Group 2 (n = 10) received the Instructional Package Form 1 in the last trimester of pregnancy. Group 3 (n = 10) received the Instructional Package, Form 1, from the first to fourth day postpartum in hospital. Group 4 (n = 10) (control group) received no instruction unless they requested it after the outcome measure was taken. 
OutcomesIncluded maternal acquisition of knowledge related to newborn and postpartum care measured using a multiple choice test of 20 questions based on the information in the package. Data were collected in the home from the fifth to thirteenth day postpartum.
NotesAntenatal and postpartum intervention for Group 1 and antenatal only for Group 2. Initially wanted sample size of 56 and then reduced it to 40. No mention of power analysis or basis for reduction. Controlled for participants’ educational level. Content validity of instructional packages assessed. No useable data.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo method of randomization described.
Allocation concealment (selection bias)Unclear riskNot discussed.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo blinding discussed.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo blinding discussed.
Incomplete outcome data (attrition bias)
All outcomes
High risk20 of initial 56 randomized lost to follow-up (36%). No reasons given. Did not give losses per group. Recruited 4 new participants after initial randomization. No intention-to-treat.
Selective reporting (reporting bias)Unclear riskOutcome reported for all groups but data not useable, as no means or standard deviations presented.
Other biasUnclear risk No mention of baseline equivalence of groups.

Regan 1995

MethodsRandomization to intervention and control group was performed using a table of random numbers. Groups were similar on age and education but differed on 'other ethnicity'. Single-centre trial.
ParticipantsIncluded 100 women who were included in the caseloads of CNMs at the University of New Mexico Hospital (USA). Inclusion criteria were: English-speaking primiparas providing written consent.
InterventionsBoth groups attended a daily nurse-conducted class and received a packet of handouts of postpartum information. The experimental group (n = 45) also received individual education by the CNM. The content and length of intervention not given. Average age of baby was 17.6 hours at intervention. The control group (n = 55) did not receive individual education.
OutcomesKnowledge of postpartum mother-infant care based on written instructions developed by nurse-midwives and measured by a 20-item true/false instrument developed by the researchers; maximum score was 20.
NotesTo control for the confounding variable of nurses' teaching, the post-test was administered prior to the usual daily nurse-conducted postpartum class.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomization using a table of random numbers.
Allocation concealment (selection bias)Unclear riskNot discussed.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo blinding discussed.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo blinding discussed.
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo losses.
Selective reporting (reporting bias)Low riskReported on outcome.
Other biasUnclear riskGroups were similar on age and education but differed on ethnicity.

Riesch 1984

MethodsRandomization to intervention and control group. Method of randomization not stated. No blinding mentioned. 2 hospital sites.
Participants2 studies were described. The first study included 108 mother-infant dyads. Inclusion criteria were: term, infants and women from 2 urban medical centres in a mid-western city, USA. The second study included 32 mother-infant dyads. Inclusion criteria were: preterm infants (34 to 37 weeks' gestation), singleton births, absence of physical malformations, absence of serious medical complications at 72 hours of age such as RDS, sepsis, convulsions, severe acid base imbalance and women from 2 urban medical centres in a mid-western city, USA. Exclusion criteria were: high-risk or ill mothers or infants including mothers with chronic illnesses, teen mothers, or mothers who required a cesarean birth.
InterventionsTerm study: 54 participants in intervention and control groups. Preterm study: 16 participants in both groups. The intervention groups received an audiotape with accompanying text which the mother listened to in her own room during a time mutually agreed upon. Visitors, calls, etc. were postponed during the listening period. The tape described neonate’s ability to demonstrate protective reflexes; to habituate to sound, light or motion; to self quiet; and to attend to objects. Appropriate maternal actions were described. Printed text was left with mother. In the term study the intervention occurred within 48 hours of infant’s birth. In the preterm study the intervention occurred within 5 days post-birth. The control groups received usual care (e.g., physical care, infant feeding, bathing).
OutcomesA 10-minute continuous observation using a checklist of 22 neonatal social behaviours and 16 maternal social behaviours, designed by researchers. Maternal self-report of her own and infant behaviours. Term study: maternal-infant interaction during an evening feeding, in hospital 24 to 72 hours post-birth. Preterm study: maternal-infant interaction during a feeding, in the home 2 to 4 days after discharge.
NotesInter-rater reliability .96 to 1.00. Content validity of instrument. No useable data.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskMethod of randomization not described.
Allocation concealment (selection bias)Unclear riskNot discussed.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo blinding discussed.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo blinding discussed.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo losses described.
Selective reporting (reporting bias)Unclear riskOutcomes reported but no usable data.
Other biasLow riskGroups equivalent at baseline for both studies.

Shapiro 1987

MethodsRandomization to intervention and control group. Method of randomization not stated. No blinding described. Multi-centre study.
ParticipantsIncluded 696 women admitted to 3 maternity wards in US hospitals.
InterventionsBoth groups received a pamphlet about burns from hot water taps and a thermometer for testing maximum water temperature. The intervention group (n = 302 at analysis) also received a 1-minute verbal summary of the dangers of hot tap water, calling the pamphlet and thermometer to their attention. The control group (n = 302 at analysis) did not receive the verbal summary. The intervention was provided on the postpartum unit. Numbers randomized to both groups were not given.
OutcomesMaternal awareness of tap water burns and greater use of temperature testing; reported as percentages.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskMethod of randomization not described.
Allocation concealment (selection bias)Unclear riskNot discussed.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo blinding discussed.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo blinding discussed.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk92 participants were lost post randomization (13%); however, no information was given on numbers lost per group. No intention-to-treat.
Selective reporting (reporting bias)Low riskAppears that all outcomes are reported.
Other biasLow riskStated major socio-demographic attributes of the 2 groups were comparable but no data given.

St James-Roberts 2001

MethodsRandomization to 2 intervention and 1 control group was determined by a computer-generated randomization schedule and placed in a sealed envelope, which was opened between days 8 and 14 in their homes. No blinding described. Single-centre trial.
ParticipantsIncluded 610 consenting women who consecutively gave birth to a live singleton infant of greater than 37 weeks' gestation on postnatal wards of a large general hospital in the UK. Exclusion criteria were: non-fluency in English, no telephone, infants with congenital anomalies or admitted to the NICU.
InterventionsBehavioural group (n = 205) received a leaflet describing a 9-point program. The educational intervention (n = 202) consisted of a 10-page guide to baby crying and sleeping that was developed with local health professionals and a telephone number for CRYSIS (a voluntary organization for parents with young babies). Guide included a question and answer section on common problems and how to deal with them and a step-by-step guide to preventing crying and sleeping problems. This highlighted the need for a regular and structured approach to care that emphasized day-night differences, recommended settling baby in a crib or other designated place and sanctioned leaving baby to fret for a few moments when judged to be suitable. It did not prescribe a focal feed. It provided written advice and suggestions that could be adapted (not prescriptions, as was the case in the behavioural intervention). The control group (n = 203) received "normal services" (also received by 2 other groups greater than 1 home visit by a health visitor nurse, clinic visits, and access to a family doctor).
OutcomesInfant crying and sleeping measured using 24-hour behaviour diaries which gave a continuous record of starting time, end time, and duration of each behaviour. These were completed at 1 week of age (baseline) and at 3, 6, 9 and 12 weeks of age.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskA computer-generated randomization schedule was used for allocation to groups.
Allocation concealment (selection bias)Low riskGroup assignment was placed in a sealed envelope, which was opened between days 8 and 14 in their homes.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo blinding discussed.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo blinding discussed.
Incomplete outcome data (attrition bias)
All outcomes
High riskAt 1 week, losses were 3%, 2% and 6% respectively for diary completion. At 12 weeks, losses were 21%, 19%, and 22% respectively for diary completion. At 9 months, there was a 19% loss in behavioural group, 18% in educational group, and 19% in control group for questionnaire completion. Intention to treat not mentioned.
Selective reporting (reporting bias)High riskSpecific comparisons of sleeping and fuss/crying not reported for 1 week and 9 months "because of large numbers of measures collected"; however no significant differences noted at these times.
Other biasLow riskGroups comparable on demographics at baseline.

Stremler 2006

MethodsRandomization centrally by computer-generated random number sequence.The groups appear comparable at baseline.The outcome assessor was blinded. Single-centre trial.
ParticipantsIncluded 30 Canadian primiparous women who had a healthy singleton baby born greater than or equal to 37 weeks' gestation, lived in greater Toronto area, planning to provide care to their infant for first 6 weeks postdischarge. Exclusion criteria were: experienced complications requiring lengthy hospital stay, previous stillbirth/neonatal death, chronic poorly controlled maternal illness, mother used medications affecting sleep, history of drug/alcohol abuse, diagnosed sleep disorder, mother's partner worked night shifts, mother unable to read or understand English, no telephone.
InterventionsIntervention group (n = 15) received TIPS (Tips for Infant and Parent Sleep). The sleep intervention included a 45-minute meeting with a nurse to discuss sleep information and strategies, an 11-page booklet, and weekly phone contact to reinforce information and problem solve. The control group (n = 15) received a 10-minute meeting during which only maternal sleep hygiene and basic information about infant sleep were discussed, a 1-page pamphlet, and calls at weeks 3 and 5 to maintain contact without provision of advice.
OutcomesIncluded 6 infant sleep measurements determined by sleep diaries and Actigraph at 6 weeks. The Actigraph detects and records continuous motion data by use of a microprocessor. Detected movements are translated into digital counts across investigator-designated recording parameters. Brief movements in the middle of sleep periods are recorded as sleep, and brief periods of no activity within time intervals of extensive wakeful movement are recorded as awake.
NotesSame research nurse provided both TIPS and control intervention. Pilot study limited to 6 weeks. Small sample. Only 6 randomized per week due to limited number of Actigraphs.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomization of groups was done using a computer-generated random-number sequence.
Allocation concealment (selection bias)Low riskRandom-number sequence was held by a research associate outside of the immediate research team.
Blinding of participants and personnel (performance bias)
All outcomes
Low riskContamination between groups was unlikely because "women were randomly assigned before discharge with little opportunity to share information before discharge". Also 1 woman per room was enrolled at a time.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskThe outcome assessor was blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo losses.
Selective reporting (reporting bias)Low riskAll outcomes reported.
Other biasLow riskGroups were similar at baseline.

Sullivan 1980

MethodsRandomization to 4 groups: 3 intervention and 1 control. Method of randomization not stated. Outcome assessors blinded. Likely single-centre trial although not clear. 
ParticipantsIncluded 53 mother-infant dyads. Inclusion criteria were: mothers were healthy, had a vaginal birth of their first or second infant. Infants were healthy and full-term. Trial conducted in Torrance, California, USA. 
InterventionsIntervention Group 1 (n = 14) received 30 minutes of unstructured early contact during the second hour postpartum plus 30 minutes of special training in infant care based on BNBAS results for their infant during the postpartum period. Intervention Group 2 (n = 12) had early contact but not training. Intervention Group 3 (n = 14) had training without early contact. Control Group mothers (n = 13) had neither early contact nor training. Intervention occurred in hospital but not clear where training was provided.
OutcomesIncluded (1) levels of attachment behaviour, (2) self-confidence, (3) competency, and (4) mutuality of interaction at 1 and 2 months based on infant physical exam, 2 structured interviews, and scoring by independent raters of videotaped feelings and interactions. Not stated where data collection occurred.
NotesNo useable data.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo method of randomization stated.
Allocation concealment (selection bias)Unclear riskNot discussed.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo blinding discussed.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessors blinded.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo mention of losses.
Selective reporting (reporting bias)High riskNot all outcomes reported. Only P values presented. Abstract only.
Other biasUnclear riskNo baseline equivalence mentioned.

Symon 2005

MethodsBlind, randomization to intervention and control groups within block sizes of 8 was performed by a specific staff member. Single-centre trial.
ParticipantsIncluded 346 families recruited from birth notification published in the only South Australian newspaper with contact details from the telephone directory. They were contacted by telephone within 2 weeks of birth. Inclusion criteria were: gave birth at 36-42 weeks' gestation; English speaking; mother planning to provide full-time care to infant for greater than 12 weeks post-birth. Exclusion criteria were: infant was admitted to the NICU within the first 2 weeks post-birth.
InterventionsIntervention group (n = 171 families) received usual care plus both parents were invited to attend a 45-minute consultation with a nurse at 2 to 3 weeks on normal sleep patterns in newborn infants and a 50-page book reinforcing the information. If infant weight gain was less than 30g/d, parents were encouraged to see their usual postnatal care provider. Control care (n = 175 families) not described.
OutcomesIncluded greater than or equal to 15 hours of total sleep per 24 hours as per sleep diary for 7 consecutive days at 6 and 12 weeks, reported as percentages. Group differences in mean number of hours for sleep time were also reported at 6 and 12 weeks, as well as mean crying time per 24 hours.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskBlind, randomization to intervention and control groups within block sizes of 8 was performed by a specific staff member. Actual method not stated.
Allocation concealment (selection bias)Low riskBlind, randomization was performed by a specific staff member.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo blinding discussed.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo blinding discussed.
Incomplete outcome data (attrition bias)
All outcomes
High riskLoss at 6 weeks was 23% in intervention group and 31% in control group. At 12 weeks, loss was 36% and 39%, respectively. Losses greater than 20%. Intention-to-treat.
Selective reporting (reporting bias)Low riskAll outcomes reported.
Other biasHigh riskHigh refusal rate before randomization (65%).Groups appear similar on the only baseline information provided: infant sex and the socio-economic status of families.

Wendland-Carro 1999

MethodsRandomization to intervention and control groups. Method of randomization not stated. Outcome coders were blind to objectives and group assignment. Single-centre trial.
ParticipantsIncluded 38 primiparous mothers and infants from Poxto Alegre, Brazil. Inclusion/exclusion criteria not given.
InterventionsThe intervention (n = 17) was designed to enhance the mother-infant interaction. On day 2 or 3 postpartum, a video covering 5 areas was viewed and discussed with the mother individually to determine what she knew, whether she had seen these infant behaviours, and what her expectations were vis-a-vis her own infant. The investigator directed the mother's attention toward the infant's potential to interact as well as the importance of affectionate handling and sensitivity toward the infant and discovering the infant's individuality. A written list describing each of these items was then given and they were encouraged to identify the behaviours in their infants. The video lasted 15 minutes, the session lasted 50 minutes. 19 dyads participated in the control group and received an intervention that emphasized basic care giving skills.
OutcomesIncluded sensitive maternal responsiveness to the infant at the end of the first month. Video tapes during free play and bathing were used to capture this. Subsequently coded as synchronous (i.e., responsiveness to the behaviour of the other in the dyad). 13 categories used. Each observation period was divided into 15-second intervals and co-occurrence of synchronous categories were determined. Reported as mean frequency of co-occurrences.
NotesSmall sample. Intercoder reliabilities exceeded 80% for all categories.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskMethod of randomization not described.
Allocation concealment (selection bias)Unclear riskNot discussed.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo blinding discussed.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome coders were blinded to objectives and group assignment.
Incomplete outcome data (attrition bias)
All outcomes
Low risk2 mothers (11%) dropped out of the intervention group after being randomized, no loss from control group. No intention-to-treat.
Selective reporting (reporting bias)Low riskAll outcomes reported.
Other biasLow riskGroups comparable at baseline except more control fathers had unskilled occupations.

Worobey 1982

  1. a

    BMI: body mass index
    BNBAS: Brazelton Neonatal Behavioral Assessment Scale
    CNM: certified nurse midwives
    IUGR: intrauterine growth restriction
    MAS: Maternal Attitude Scale
    MS: multiple sclerosis
    NICU: neonatal intensive care unit
    RDS: respiratory distress syndrome
    REST: Regulation, Entrainment, Structure, and Touch
    SIDS: sudden infant death syndrome
    vs: versus

MethodsRandomization to 3 groups: intervention, contrast, and control. Method of randomization not described. Mothers were blinded to the hypotheses. Outcome assessors blinded to experimental design and purpose of study. Single-centre trial.
ParticipantsIncluded 48 mother-infant dyads from the Centre Community Hospital, State College, Pennsylvania, USA. Inclusion criteria were: healthy, full-term newborns.
Interventions16 dyads randomized per group. The 1-on-1 intervention consisted of 3 methods of relaying information from BNBAS. The control group (minimal information through auditory feedback) received usual care which consisted of a verbal description of their newborn’s performance on the BNBAS immediately following the assessment lasting approximately 15 minutes. The contrast group (passive observation with auditory and visual feedback) watched the examiner administer the BNBAS on their infants and received a verbal description of their infant behaviour as well as a 1-page summary 2 days later. The assessment lasted approximately 45 minutes. It occurred on the second or third day post-birth. The intervention group (active information through auditory, visual, and tactile interaction) were guided through an interaction with their newborns in which they administered the BNBAS. The facilitator did not touch the infant but rather guided the mother through the procedure. The intervention lasted approximately 45 minutes on the infant’s second or third day. These mothers also received a 1-page summary
OutcomesAt 4 to 6 weeks post-birth, dyads were observed for an hour in the home before, during, and after a bathing session. Maternal-infant behaviours were observed and documented on a pre-coded check list each time a behaviour from 16 behaviour categories occurred in a 15-second period. 5 a priori clusters of behaviours were used to create scores: (1) contingent interaction, (2) embellished maternal involvement, (3) simple maternal attention, (4) basic maternal care, and (5) infant behaviour. 
NotesInter-rater reliability between observers .87 to .99. No useable data.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskMethod of randomization not described.
Allocation concealment (selection bias)Unclear riskNot discussed.
Blinding of participants and personnel (performance bias)
All outcomes
Low riskMothers were blinded to the hypotheses.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessors blinded to experimental design and purpose of study.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo mention of losses.
Selective reporting (reporting bias)Unclear riskAll outcomes reported but no useable data.
Other biasLow riskGroups equivalent at baseline

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
  1. a

    NICU: neonatal intensive care unit
    RCT: randomized controlled trial

Adam 1985Study is not a RCT.
Akai 2008Not a structured form of postnatal education. Home-based support program. On average infants were 4.3 months old at start of intervention. Mother-infant dyads participated for about 4.5 months and then outcomes measured when infants were approximately 9 months of age.
Baqui 2008Part of an antenatal education and postnatal preventative and curative newborn care intervention for community health workers not parents.
Barlow 2013Study of teen parents.
Barr 2009Not a structured form of postnatal education. Study is not exclusively a postpartum intervention. Education started prenatally.
Bashour 2008Home visitation program, not a clear structured educational intervention.
Beal 1989Study is not a RCT - alteration of assignment to groups, no random start.
Beiler 2011Not a structured form of postnatal education. Office-based versus home-nurse visits.
Bristor 1984Study is not a RCT, no randomization of groups.
Cevasco 2008Singing songs is not a structured form of postnatal education.
Cohen 1980Study is not a RCT, although the abstract indicated it was.
Cupples 2011Study is not exclusively a postpartum intervention. Education began twice monthly during pregnancy.
Dihigo 1998Study is not a RCT - randomization to 2 treatment groups only, not control group.
Doherty 2006Study is not exclusively a postpartum intervention and results were not presented separately.
French 20125 time periods for intervention up to 12 months postpartum. Not able to separate out the 2-week and 2-month interventions.
Glazebrook 2007Parents of infants in NICU.
Goyal 2009Not a RCT. Also not an educational intervention. Support for postpartum depression.
Hansen 1990Study is not exclusively a postpartum intervention and results were not presented separately for intervention received at 0 to 2 months.
Hawkins 2008Couples had already enrolled in Welcome Baby program prior to being randomly assigned to 1 of the 2 treatment groups. Assignment to control group was not randomized. First 40 couples who were not interested in Welcome Baby program but were interested in being in study were enrolled in control group. Postnatal education did not start until 3 months after birth. Data collected for post-tests at 4-5 months and again 9-10 months postpartum.
Ho 2009A support-based intervention for postpartum depression not a structured form of postnatal education.
Kabakian-Khasholian 2005Study outcomes were related to women's use of postpartum services.
Kemp 2011Not a structured form of postnatal education. A home-based support intervention. Started in the prenatal period.
Kistin 2011Not a structured form of postnatal education.
Lee 2012Intervention not related to infant health/care or infant-parent relationships. Intervention related to women's postpartum sexual health behaviours.
Leff 1988Study is not a RCT - 2 intervention groups and no control group.
Morrell 2000Study does not test an educational intervention.
Niccols 2008Parenting program not within 2 months postpartum; infants from 1-24 months.
Petch 2012Study is not exclusively a postpartum intervention. Education began in the prenatal period.
Reich 2010Not a structured form of postnatal education. Study is not exclusively a postpartum intervention. Education began in the third trimester of pregnancy.
Rotheram-Borus 2011Not a structured form of postnatal education. Study is not exclusively a postpartum intervention. Home-based support program, intervention began with 4 antenatal visits.
Santelices 2011Study is not exclusively a postpartum intervention. There were 6 prenatal group sessions.
Scott 1990Infants recruited at less than 18 months; no data presented separately for infants receiving the intervention prior to 2 months old.
Shapiro 2011Study is not exclusively a postpartum intervention. Workshop was completed during pregnancy.
Simons 2001Study is not a structured teaching intervention and effect of education not isolated from other intervention components.
Spigelblatt 1991Study is not a RCT although the study title indicated that it was.
Wagner 1999Study does not focus on infants less than 2 months old.
Waterston 2009Postnatal education was beyond 2 months postpartum. The newsletter went through the first 12 months postpartum.
Wen 2011Home-based support program, intervention started in the prenatal period.
Wolfson 1992Study is not exclusively a postpartum intervention. Education started prenatally.

Characteristics of studies awaiting assessment [ordered by study ID]

Kim 2004

  1. a

    RCT: randomized controlled trial

MethodsNot clear if this study is a RCT. It is written in Korean except for the tables. Attemping to secure a translation.
Participants35 mothers and their infants.
InterventionsEducation related to sensory stimulation administered twice a day.
OutcomesInfant growth, mother-infant interaction.
Notes 

Characteristics of ongoing studies [ordered by study ID]

Cook 2012

  1. a

    RCT: randomized controlled trial

Trial name or titleBaby business: A randomized controlled trial of a universal parenting program that aims to prevent early infant sleep and cry problems and associated parental depression.
MethodsRCT
Participants750 English speaking parents in Australia with healthy newborns greater than 32 weeks' gestation.
InterventionsExperimental group receives Baby Business program providing information to parents about infant sleep and crying via DVD and booklet mailed soon after birth and telephone consultation at 6-8 weeks postpartum. Control groups receives usual care.
OutcomesParent report of infant night time sleep as a problem at 4 months, parent report of infant day time sleep or crying as a problem, mean duration of infant sleep and crying/24 hours, parental depression symptoms, parent sleep quality and quantity and health service use.
Starting date2011
Contact informationFallon Cook at fcook@parentingrc.org.au
Notes 

Ancillary