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Early skin-to-skin contact for mothers and their healthy newborn infants

  1. Elizabeth R Moore1,*,
  2. Gene C Anderson2,
  3. Nils Bergman3,
  4. Therese Dowswell4

Editorial Group: Cochrane Pregnancy and Childbirth Group

Published Online: 16 MAY 2012

Assessed as up-to-date: 15 MAR 2012

DOI: 10.1002/14651858.CD003519.pub3

How to Cite

Moore ER, Anderson GC, Bergman N, Dowswell T. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database of Systematic Reviews 2012, Issue 5. Art. No.: CD003519. DOI: 10.1002/14651858.CD003519.pub3.

Author Information

  1. 1

    Vanderbilt University, School of Nursing, Nashville, Tennessee, USA

  2. 2

    Professor Emerita, University of Florida, Case Western Reserve University, Gainesville, FL, USA

  3. 3

    University of Cape Town, School of Child and Adolescent Health, and Department of Human Biology, Cape Town, South Africa

  4. 4

    The University of Liverpool, Cochrane Pregnancy and Childbirth Group, Department of Women's and Children's Health, Liverpool, UK

*Elizabeth R Moore, School of Nursing, Vanderbilt University, 314 Godchaux Hall, 21st Avenue South, Nashville, Tennessee, 37240-0008, USA. elizabeth.moore@vanderbilt.edu.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 16 MAY 2012

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Characteristics of included studies [ordered by study ID]
Anderson 2003

MethodsRandomized controlled trial (computerized minimization technique).


Participants91 healthy preterm infants 32-36 weeks' gestation and their mothers. Only data from the 31 infants on the postpartum unit were included in the analysis; the 60 NICU infants were excluded. Mean GA of the included infants was 35.6 weeks. There were no significant between group differences in socio- demographic or medical characteristics in this sub-group of infants except 5-min Apgar scores. The mean 5-min Apgar score was 9.0 in the SSC group and 8.5 in the control group.


Interventions1) SSC group = diaper clad infants placed prone and SSC between their mother's breasts as soon as possible for as long as possible postbirth. Along with SSC, mothers also held their infants wrapped in blankets. 2) Control group = infants kept warm in incubators, warmer beds, bassinets or held wrapped in blankets.

Process outcomes include mean % contact time during hours 0-48 spent in SSC or wrapped holding by mother, father or others and mean % noncontact time (no hold) hours 0-48 postbirth.


OutcomesMother preterm infant interaction (MPI) measured by mean scores on the Nursing Child Assessment Satellite Training Program (NCAST) Feeding and Teaching scales at 6,12 and 18 months postbirth (reported in Chiu 2009 using the same data set). Breastfeeding status (exclusivity) at hospital discharge, 6 weeks, 3, 6, 12 and 18 months postbirth (reported in Hake-Brooks 2008 using the same data set).


NotesStudy was done in the USA at 2 different hospitals 1 on Cleveland, Ohio and the other in Richland, Washington. Participants were mixed parity.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomization was by a computerized minimization program.

Allocation concealment (selection bias)Low riskSealed, sequentially numbered opaque envelopes containing the next group assignment were used for the first 10 participants to prevent selection bias.The rest of the participants were assigned to groups using the minimization technique. Informed consent was obtained during early labor.

Mother-infant dyads were randomly assigned to groups immediately postbirth.

Blinding (performance bias and detection bias)
All outcomes
Low riskThe research staff involved in evaluating MPI data at 6,12 and 18 months postbirth using a videotaped infant feeding and teaching session were unaware of the mother's group assignment.

The nurse researcher who collected Index of Breastfeeding Status (IBS) scores was blind to participant group assignment.

Incomplete outcome data (attrition bias)
All outcomes
Low riskAt 6 months postbirth, 2/15 infants were missing from the SSC group and 2/14 from the control group; at 12 months postbirth 2/15 infants were missing from the SSC group and 2/14 from the control group, at 18 months postbirth 3/15 infants were missing from the SSC group and 2/14 from the control group. At 3 and 6 months postbirth 1/11 breastfeeding SSC infants had missing data on the IBS. At 6 weeks postbirth 1/12 breastfeeding control infants had data missing on the IBS, at 3 months postbirth 3/12 infants had missing data.

Selective reporting (reporting bias)Low riskNumerical data (M,SD) were reported by group assignment for the NCAST feeding scales at 6 and 12 months, and the NCAST teaching scales at 6, 12 and 18 months postbirth.

Numerical data were reported for the IBS N,n,% in each breastfeeding category at hospital discharge, 6 weeks postbirth and at 3,6,12 and 18 months postbirth.

Other biasUnclear riskIn the SSC group the nurse researchers provided breastfeeding assistance with the initial feedings. The control mothers received standard hospital care. Lactation consultants provided breastfeeding assistance if the mother requested help and if they were available.

Bergman 2004

MethodsRandomized controlled trial (computerized minimization technique).


Participants35 healthy late preterm infants and their mothers. Mean GA SSC group 34.2 weeks, control group 35.3 weeks.


InterventionsAll infants had a brief period of SSC immediately postbirth. 1) SSC group = after the 5-min Apgar the naked infant was secured to their mother's chest by a towel. A shirt with long ties was placed around the mother's waist to secure the baby below. The dyad was transferred to the observation area of the neonatal unit at 60 min postbirth. SSC was continuous for at least 6 hours 2) Control group = after the 5-min Apgar the infant was transferred to an incubator which remained with the mother in the delivery room for 60 min. At 1 hour the infant in the incubator was transferred to the observation area of the neonatal unit.


OutcomesTransfers to NICU, exceeded parameters -temp < 35.5, HR < 100 >180 BPM, Apnea > 20s, O2 sat < 89%, blood glucose < 2.6, SCRIP score during the first 6 hours postbirth, SCRIP score in the 6th hour postbirth.


NotesStudy was done with indigent participants in 2 secondary level referral hospitals in Cape Town, South Africa.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk“computerized minimisation method”. Range of factors taken into account in the minimization process in an attempt to reduce confounding.

 

Allocation concealment (selection bias)Low riskComputerized method of allocation following ascertainment of eligibility (5-min Apgar score) by nurse researcher present at delivery or by mobile phone.  

Blinding (performance bias and detection bias)
All outcomes
Unclear riskWomen and staff present during intervention would be aware of allocation but, it is not clear whether this was likely to have had an impact on most of the types of outcomes measured and there was an attempt to standardize other aspects of care. The nurse carrying out randomization was involved in other aspects of care such as breastfeeding instruction. For many outcomes reported (physiological measurements) most were continuously recorded on monitors and unlikely to have been subject to bias. Clinical decisions re admission to NICU could not be standardized.

Incomplete outcome data (attrition bias)
All outcomes
Low risk35 randomized.1 woman in the intervention group was excluded postrandomization as she was no longer eligible. The remaining 34 remained available for the primary outcome (NICU admission) and the remaining 31 were followed up for 6 hour measurements. Intention-to-treat analysis for primary outcome.

Selective reporting (reporting bias)Unclear riskNot apparent, although risk of bias was carried out using published study report.

Other biasUnclear riskThe initial power calculation suggested a sample size of 64 and the investigators planned to recruit 100 women. There were logistical difficulties in recruitment that may have led to selection biases and this may reduce the generalizability of findings. The 2 study groups were of different sizes; this occurred by chance. Difficulties in recruitment led to interim analysis and as results favored the intervention group, the study was discontinued.

 

Baseline imbalance: not apparent.

Bystrova 2003

MethodsRandomized controlled trial (envelope with group assignment).


Participants176 healthy full term infants and their mothers were divided into 4 treatment groups.


InterventionsAll infants were immediately placed under a radiant warmer, dried, washed, weighed, given eye prophylaxis and cord care during the first 22 min postbirth.
1) SSC group = 37 babies were placed prone and SSC on mother's bare chest for approximately 90 min and then roomed-in (swaddled or dressed) on the maternity ward and breastfed on demand. 2) Mother's arms group = 40 babies were clothed (swaddled or dressed) and placed prone on their mother's bare chest.for approximately 90 min and then roomed-in on the maternity ward and breastfed on demand. 3) Nursery group = 38 babies were clothed (swaddled or dressed) and taken to the nursery immediately postbirth and remained there while their mothers were on the maternity ward except for breastfeeding 7 times a day. 4) Reunion Group = 38 babies were clothed (swaddled or dressed) and taken to the nursery immediately postbirth, but roomed-in with their mothers on the maternity unit and breastfed on demand.


OutcomesMean difference in infant axillary, interscapular, thigh temperatures and foot temperature change from 30 to 120 min postbirth (Bystrova 2003). Amount of milk ingested (before and after breastfeeding infant weights), volume of supplemental feedings, number and duration of breastfeedings day 4 postbirth, recovery of infant weight loss day 3-5 postbirth (reported in Bystrova 2007a). Number of breastfeedings, physiological breast engorgement, feeling low/blue days 1-3 postbirth, duration of nearly exclusive breastfeeding (reported in Bystrova 2007b). Maternal breast and axillary temperature, (reported in Bystrova 2007c). Assessment of mother-child interaction at 12 months postbirth using the Parent-Child Early Relational Assessment (PCERA) (reported in Bystrova 2009).


NotesStudy was done in St Petersburg, Russia.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAn experimental 2 factor design (baby's location, apparel) was used. The randomization sequence was blocked for time and parity. Randomization to the 8 treatment combinations occurred in blocks of 8 mothers independent of the other blocks and separated by parity.

Allocation concealment (selection bias)Low riskInformed consent was obtained during labor. Random assignment occurred immediately after birth. Sealed, numbered, opaque envelopes were opened sequentially. The research report stated that "both the researchers and the recruited women were blind to the task".

Blinding (performance bias and detection bias)
All outcomes
Unclear riskThe psychologists who evaluated videotaped mother-child interactions at 12 months postbirth using the PCERA were blind to group assignment. The videotaping was also performed by a psychologist who was blind to group assignment. No information was provided about whether the researchers who evaluated the other outcomes in these research reports were blind to group assignment. The evaluators of some of the outcomes, for example, infant temperatures taken during SSC, could not be blind to group assignment.

Incomplete outcome data (attrition bias)
All outcomes
Low risk176 mothers were randomly assigned to the 4 main treatment groups. 23 mothers were excluded during their stay on the maternity ward for various reasons which were listed in the research report. There were no significant between group differences in background variables between the 23 mothers who were excluded and the 153 who remained in the study. 9 mothers were lost to follow-up at 1 year. Reasons for their exclusion were provided. An additional 20 mother-infant pairs were excluded from the PCERA assessments 12 months postbirth. Reasons for their exclusion were provided.

Selective reporting (reporting bias)Low riskNumerical data were provided for all outcomes except recovery of infant weight loss day 3-5 postbirth (Bystrova 2007a) however, between the 4 groups, differences were reported to be insignificant. The results of the statistical tests and P values were reported for all outcomes in Bystrova, IBJ, 2007). However, the M, SE was used instead of M, SD for the descriptive statistics. Data for the mean maternal axillary and breast temperatures were plotted on a graph for the 7 time points for data collection in Bystrova 2007c. The SE rather than the SD was used as the measure of dispersion. Data for the infant's foot and axillary temperatures were recorded in Bystrova 2003. Results of the statistical tests for the SSC group compared with the other groups were provided for 2/8 of the PCERA composite variables, child disregulation and irritability and dyadic mutuality and reciprocity. The results for the other composite variables were not reported but were stated as insignificant (Bystrova 2009). Additional statistical data was obtained from the researchers.

Other biasUnclear riskData were reported using "per protocol" rather than "intention to treat" analysis.

Carfoot 2004

MethodsRandomized controlled trial (sealed envelopes).


Participants26 healthy full term infants > 36 weeks' gestation and their mothers.


Interventions1) SSC group = mothers given infants to hold prone between their breasts and covered with a warm blanket as soon as possible postbirth. Midwives assisted with the 1st breastfeeding. 2) Control group = babies dried, wrapped in a towel and handed to mom or dad. Midwives assisted with the 1st breastfeeding.


OutcomesSuccess of the 1st breastfeeding (BAT score 8-12), type of feeding at 4 months postbirth (exclusive breastfeeding, mixed feedings, artificial feedings).


NotesStudy was done in Cheshire, UK.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated randomization list.

Allocation concealment (selection bias)Unclear riskSequence of sealed envelopes (not clear if opaque) and not clear whether the envelopes were numbered and opened in sequence. 

Blinding (performance bias and detection bias)
All outcomes
Unclear riskThere was no blinding in this study. It is possible that the lack of blinding may have affected women’s responses and behavior, that clinical care other than skin to skin contact may also have differed by randomization groups and outcome assessors would be aware of allocation during the first feed (observed) and this may have affected their observations.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskPilot study including 26 mother infant pairs looking at study feasibility (data on review outcomes not reported).        

Selective reporting (reporting bias)Unclear riskAssessment from published study report only.

Other biasLow riskOther bias not apparent.

Carfoot 2005

MethodsRandomized controlled trial (sequence of sealed envelopes containing next allocation from a computer-generated randomization list).


Participants204 healthy full term infants > 36 weeks' gestation and their mothers.


Interventions1) SSC group = mothers given naked infants to hold prone between their breasts and covered with a warm blanket as soon as possible postbirth. Midwives assisted with the 1st breastfeeding. 2) Control group = babies dried, wrapped in a towel and handed to mom or dad. Midwives assisted with the 1st breastfeeding.


OutcomesSuccess of the 1st breastfeeding (BAT score 8-12), success of a subsequent breastfeeding, mean temperature 1 hour postbirth, maternal satisfaction with care, preference for same postdelivery care in the future, type of feeding at 4 months (exclusive, partial breast, formula feeding).


NotesStudy was done in Cheshire, UK.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated randomization list.

Allocation concealment (selection bias)Unclear riskSequence of sealed envelopes (not clear if opaque) and not clear whether the envelopes were numbered and opened in sequence. 

Blinding (performance bias and detection bias)
All outcomes
Unclear riskThere was no blinding in this study. It is possible that the lack of blinding may have affected women’s responses and behavior, that clinical care other than skin to skin contact may also have differed by randomization groups and outcome assessors would be aware of allocation during the first feed (observed) and this may have affected their observations.

Incomplete outcome data (attrition bias)
All outcomes
Low risk325 women initially approached and 244 agreed to take part (75%). 204 women randomized data and 197 observed at 1st data collection point  (with analysis according to randomization group) and data available for 197 women at 4 month follow-up.       

Selective reporting (reporting bias)Unclear riskAssessment from published study report only.

Other biasLow riskOther bias not apparent.

Baseline characteristics appeared similar.

Carlsson 1978

MethodsRandomized controlled trial.


Participants62 healthy, full term infants. The mothers were randomized into 1 of 3 groups before delivery.


Interventions1) Extended contact-new routine group = kept their naked infants for 1 hour immediately postbirth, mothers cared for infants. 2) Extended contact-old routine = kept their naked infants immediately postbirth for 1 hour, staff cared for infants. 3) Limited contact-old routine group = held their infants for 5 min immediately postbirth, staff cared for infants.


OutcomesObservation of maternal behavior (contact behavior and behavior not implying contact with baby) by videotape during breastfeeding on day 2 and 4 postbirth.


NotesStudy was done with middle-income primipara in Sweden.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod used to generate the randomization sequence were not described.  The study involved “randomly selected” women who were “randomly assigned” to 1 of the 3 study groups.

 

Allocation concealment (selection bias)Unclear riskThe method used to conceal group allocation at the point of randomization was not described. 

Blinding (performance bias and detection bias)
All outcomes
Unclear riskIt was stated that participants “were unaware of the purposes of the study”. However, presumably women would be aware that they were being observed when they were feeding their babies. Clinical staff caring for women may have been aware of early contact and it was not clear whether the staff carrying out observations were aware of group allocation.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk62 women were randomized. 50 were available for follow up (81%) and full observational data were available for 46 (74%). Loss appeared to be reasonably balanced across groups.         

12/62 women lost to follow up and there were further missing data.

Selective reporting (reporting bias)Unclear riskAlthough observation methods were described it is not clear what the main study outcome means (frequency of mother/infant contact/not contact during breast or bottle feeding) . The frequencies were presented as means with SEs. The average number of observation points during a feed would be approximately 100, but the mean figures are closer to 200 so it seems more than 1 behavior was noted in each observation period. However, it was stated that if the same behavior (which may have been a contact behavior) occurred more than once in any observation period it was only recorded once. It is possible therefore that continuous high contact behavior was rated as being of lower contact value than rapidly changing behaviors.

Several results were not presented according to randomization group and results were difficult to interpret.               

Other biasUnclear riskBaseline imbalance not apparent.

 

Other: Results were difficult to interpret and 2 groups that received different treatments were merged for some results but not others.

Christensson 1992

MethodsRandomized controlled trial.


Participants50 full term infants and their mothers randomized after the delivery.


Interventionsa) 80 min of SSC with the mother, b) 80 min in a cot.


OutcomesAxillary, thigh, and interscapular temperatures. Duration of crying. Blood glucose, base excess, respiratory rate, HR after 90 min.


NotesStudy was done in Madrid, Spain.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethods to generate the allocation sequence were not described. 

Allocation concealment (selection bias)Unclear riskVery little information on study methods. Described as “allocated randomly”.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskWomen would be aware of group allocation. It is not likely that this affected outcomes such as temperature but it may have affected baby behavior (it appeared that mothers in the cot group were advised not to pick their babies up even if the baby was crying).

Clinical staff and observers were not blind to group allocation. It is difficult to know whether this had any effect on temperature recording. The observation of crying may have been affected by knowledge of group allocation

Incomplete outcome data (attrition bias)
All outcomes
Low riskIt appeared that all women randomized were followed up, randomization seemed to occur before delivery and it appeared that no women were excluded following randomization (as they became ineligible due to complications in labor, etc).

 

Selective reporting (reporting bias)Unclear riskDifficult to assess  without access to study protocol. Multiple observation points means that results for temperature are difficult to interpret. Results for crying are also difficult to interpret as mothers in the cot group were discouraged from picking up their babies during the observation period even if they were crying.                 

Other biasUnclear riskNo power calculations reported.

Baseline characteristics in the 2 groups appeared similar. Very little information was provided on study methods

Christensson 1995

MethodsRandomized controlled trial.


Participants44 full term infants and their mothers immediately postbirth.


InterventionsGroup a) 76-85 min of SSC with the mother, b) infant in a cot for 76-85 min, c) infant in a cot for 35 min then SSC for 45 min.


OutcomesDuration of crying, axillary temperature 90 min postbirth.


NotesStudy was done in Madrid, Spain.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot described “allocated randomly”.

 

Allocation concealment (selection bias)Unclear riskNot described (allocation was before delivery but women and staff were not informed of the allocation until after delivery).

Blinding (performance bias and detection bias)
All outcomes
Unclear riskParticipants and staff were not blinded. It is not clear whether knowledge of allocation would have affected maternal behavior and responses (for those in the “cot” group, women were asked not to move the baby). Staff providing care may have altered other aspects of care. Outcome assessors were blinded (blind assessment of audiotapes – although presumably they would also hear the mother and other noise so may have been able to ascertain group assignment).

 

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDue to mechanical failures there were missing data for the primary outcome.44 women were randomized and audiotape data were available for 33 (75%).

Selective reporting (reporting bias)Unclear riskAssessed from published study report.     

Other biasUnclear riskDescribe any baseline in balance: Not apparent, but sample size was small so imbalances between groups although not statistically significant may have been important (e.g. cot group 7/14 primips, s to s 5/15 primips).

Chwo 1999

MethodsRandomized controlled trial (computerized minimization technique).


Participants34 healthy late preterm infants 34-36 weeks' gestation and their mothers.


Interventions1) SSC group = SSC and on cue self-regulatory feedings during 6 1-hour feeding periods beginning M = 21 hours postbirth. The infant, in a small diaper, was placed on the ventral surface of their mother's torso. 2) Control group = infants held wrapped in blankets during 6 1-hour feeding periods beginning M = 23 hours postbirth.


OutcomesInfant body weight change day 14 and 28 postbirth, length of stay in the hospital, tympanic temperature change and variability, behavioral state inactive awake, drowsy, crying during feedings.


NotesStudy was done in a teaching hospital near Taipei, Taiwan.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated minimization process with stratification for gender, birthweight, mode of delivery and parity.

 

Allocation concealment (selection bias)Low riskComputerised allocation. Not clear how the process was carried out at the point of group allocation.

Blinding (performance bias and detection bias)
All outcomes
High riskWomen in both the control and intervention did not receive usual care and would likely to have been aware of group assignment. Staff providing care and breastfeeding advice also collected outcome data. This may have had an impact on some outcomes – particularly the observation of infant behavior.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk34 women followed up in hospital by day 14 23 infants available to follow up and 26 on day 28

Selective reporting (reporting bias)Unclear riskAssessment carried out using published study report only.                  

Other biasUnclear riskThe intervention may not be generalizable to other babies in the same study setting. The intervention was described as KC but infants were not in SSC until 4 hours after the birth, then contact was for 1 hour at 4-hourly intervals at specified feeding times for 6 feeds. Control infants were offered the same contact but babies were in blankets, both groups were given advice and support from the observer. It was not clear how much time infants spent feeding during the observation period.

Groups were reported to be similar at baseline.

Craig 1982

MethodsRandomized controlled trial (sealed envelopes prepared using a table of random numbers by gender).


Participants60 healthy full term infants and their mothers.


Interventions1) Control group = mothers held their wrapped infants for 3 min then contact at feedings every 4 hours. 2) Early SSC group = infants were placed in SSC on their mother's chests for 54 min then contact at feedings every 4 hours.


Outcomes1) Neonatal Perception Inventory. 2) Interview of mother's experiences during pregnancy, delivery, 1st postpartum month. 3) Questions about infant behavior during a home visit at 1 month postbirth.


NotesStudy was done with low-income primapara in the USA.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskTable of random numbers.

Allocation concealment (selection bias)Unclear risk“ sealed envelopes” (not clear if opaque and used in sequential order or if any envelopes were discarded)  “Separate envelopes were prepared for male and female infants to insure a comparable sex distribution in each contact group”.

Blinding (performance bias and detection bias)
All outcomes
Unclear risk“Mothers given extra contact were not aware that their care differed from that given to other patients”. “Patients were told that the investigators wished to study maternal-infant relationships during the first postpartum month.”

Staff caring for women would be aware of group assignment during the early postpartum period. The principal investigator recruited mothers and collected most of the outcome data. An attempt was made to check whether the data collected by this investigator and another researcher; there was no evidence of bias. 

Incomplete outcome data (attrition bias)
All outcomes
High riskThere was serious attrition and missing data at some data collection points. 60 women were recruited; outcome data at 1 month were available for 49 (81.7%). Loss was reported to be balanced between groups . 24 of the sample (40%) completed a behavioral record.                                                       

Selective reporting (reporting bias)Unclear riskData reported as in introduction, but not clear if other data collected. (Assessment from published paper only.)                   

Other biasUnclear riskBaseline imbalance not apparent.

Some results were difficult to interpret. It appeared that mean scores had been calculated from a 4-point category measure.

Curry 1982

MethodsRandomized controlled trial (sealed envelopes).


Participants20 healthy full term infants randomized during the first hour postbirth.


Interventions1) Control group = held their wrapped infants for 36 min during the first hour postbirth. 2) SSC group = held their infants in SSC for 35 min during the first hour postbirth. Both groups had 12 hours of rooming-in during the day.


Outcomes1) 7 maternal attachment behaviors (en face, kiss, hold, encompass, close contact and smile at) measured at 36 hours and 3 months postbirth during breastfeeding. 2) The Tennessee Self Concept measured at 2 months postbirth.


NotesStudy was done with well-educated, married, middle-income, Caucasian, breastfeeding primipara in the USA.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskIn batches of 10, 5 envelopes each contained control or intervention allocations.

 

Allocation concealment (selection bias)Unclear riskDark brown envelopes containing allocations  were shuffled and an envelope selected. When 10 envelopes had been used a further 10 were prepared, then 1 of each allocation for last 2 random assignments.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskIt was stated that mothers were not told the precise reasons for the study, although mothers would be aware of the intervention. The staff taking infant temperatures during the intervention period would be aware of allocation. It was stated that the investigators collecting outcome data at 36 hours and at 3 months was not aware of group, although mothers may have revealed this during interviews.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk56 women were recruited, but at the point of randomization only 20 women remained. Only women delivering while the researcher was on the premises were included. Not clear exactly when randomization occurred.

Selective reporting (reporting bias)Unclear riskUsed observation as main outcome which is difficult to interpret. Results reported as mean occurrence of attachment behaviors, it is not clear whether the same mother could exhibit lots of behaviors.  Mean number of behaviors during the same length of observation period appeared considerably less at 3 months follow-up compared with 36 hrs.                

Other biasUnclear riskBaseline imbalance not clear, small sample size.

Less than half of the eligible sample was recruited.

De Chateau 1977

MethodsRandomized controlled trial (open random numbers table).


Participants62 healthy full term infants and their mothers. Group 1 primiparous mothers and their infants n = 22. Group 2 primiparous mothers and their infants n = 20. Group 3 multiparous mothers and their infants n = 20.


InterventionsGroup 1: 15-20 min of SSC during the first hour postbirth. The infants were placed on the breast at 10 min postbirth and assisted by the midwives with breastfeeding. Groups 2 and 3 = routine care. The dressed babies were placed in a crib at the mother's bedside or in her bed at 10 min postbirth.


OutcomesObservation of mother's behavior during breastfeeding at 36 hours postbirth. Mother's and infant's behavior at 3 months during free play.
Breastfeeding at 3 months, 1 year postbirth. Mother's and infant's behavior during a physical exam and infant development at 12 months.


NotesStudy was done with middle-income women in Sweden. 2-arm trial with individual randomization (a 3rd group of women (multips) were also included as a comparison group in 1 of the reports but this group was not randomly allocated and is not included in the analyses).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High risk“Immediately after delivery, the midwife or auxiliary compared the number on the mother’s record with a coincidence table... placed in an office outside the delivery room – the primiparous mothers were randomly assigned”.

Allocation concealment (selection bias)High riskAllocation according to open list after delivery.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskIt appeared that women were not aware that the intervention was part of a study, they were told that the observation was to examine mother infant behavior during breastfeeding. Staff providing care would be aware of the allocation. It was stated that observation was carried out by staff who “did not know to which group the mother-infant pairs belonged”. It was not clear whether other data were collected by blind observers.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk 42 women were randomized. 1 woman from the intervention group was not observed at 36 hours. At 1 year follow up there were 33 remaining; of the 9 lost to follow up, 5 were described as belonging to the “lowest socioeconomic category”. There were some further missing data.

Selective reporting (reporting bias)Unclear riskData collected by observation difficult to interpret. It appeared that women could contribute different numbers of observations to mean scores.                  

Other biasUnclear riskNo baseline imbalance apparent.

There was some discrepancy between results in the text and tables in 1 of the papers. Denominators for some outcomes were not clear.

Fardig 1980

MethodsRandomized controlled trial (blind drawing of 1 of 3 numbers with replacement).


Participants51 uncomplicated infants with gestation 38-42 weeks, birthweight of at least 2500 g, normal labor and delivery and normal Apgar score.


InterventionsGroup 1 infants were suctioned, dried under a radiant heater for 5 min and then placed naked on the mother's bare chest for 25 min. The infant's back was then covered with 2 cotton blankets. Group 2 infants were placed naked directly on the mother's chest for 28 min after the umbilical cord was cut. Group 3 infants were placed under a radiant warmer without being placed on the mother's chest.


OutcomesSkin temperature measured on the infant's left side every 3 min for 45 min. Rectal temperature at 21 and 45 min. Outcomes were the number of infants with skin or rectal temperature in the neutral range at 21 or 45 min.


NotesStudy was done in the USA.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskDrawing numbers.

Allocation concealment (selection bias)Unclear riskWomen were “randomly assigned to either the control group or to 1 of the experimental groups by blind drawing of 1 of 3 numbers, with replacement.” This suggests that group allocation could be changed by the investigator.

Blinding (performance bias and detection bias)
All outcomes
High risk”Both the couple and their caregiver were told how the baby would be handled after delivery.” Researcher collecting outcome data would also be aware of group assignment.

Incomplete outcome data (attrition bias)
All outcomes
Low riskDescribe any loss of participants to follow-up at each data collection point: It appeared that all women were accounted for at each data collection point. It was not clear if there was any missing data.

Selective reporting (reporting bias)Unclear riskMost outcomes appear to have been reported

Other biasUnclear riskAuthors reported that there were no significant differences between groups for a number of variables but the data were not shown. It was not clear how many of those eligible were approached to take part or whether recruitment only occurred at particular times (e.g. was the same researcher available at night and weekend) nor whether women who had long labors remained in the study. It is not clear whether women were excluded postrandomization if there was any intrapartum problem.

Ferber 2004

MethodsRandomized controlled trial (table of random numbers).


Participants42 healthy full term infants 38-42 weeks' gestation and their mothers.


InterventionsAll newborns were placed on mother's chest for 5-10 min, then dried, weighed and dressed. 1) SSC group = infants brought back to mom 15-20 min postbirth, undressed, placed SSC between the mother's breasts and covered with blankets for 60 min. Then the infants were taken to the newborn nursery for 4 hours of observation. 2) Control infants were taken to the newborn nursery, placed under a warmer for 5-10 min, swaddled and laid in a bassinet. They were brought back to their mothers at 5 hours postbirth.


OutcomesOptimal respirations, motor disorganization, visceral stress response, optimal flexed movements, extension movements, facial movements, sleep state, drowsy, fussy and crying states, positive attention signs, negative attention signs.


NotesStudy was done in Haifa, Israel with primarily middle- to upper-middle class European, African and Arab mothers.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom number tables, the sequence was generated by a different person from the 1 carrying out recruitment and group assignment.

 

Allocation concealment (selection bias)Unclear riskNot described.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskIt was stated that mothers were not aware of group assignment as mothers in each group were kept separate (it was not clear how the study was described to mothers or how consent was obtained). Those staff caring for mothers after the birth would be aware of group assignment and other aspects of care may have differed. It was stated that staff in the newborn nursery (where outcomes were assessed) were blind to group assignment but it was not clear how effective this blinding would be as babies in the control and intervention arms were admitted at different times after birth (and this would be stated on notes). It was stated that outcome assessment was done by blind observers, it was not clear whether attempted blinding was successful.

Incomplete outcome data (attrition bias)
All outcomes
Low riskRandomization was carried out at the start of labor. 50 women were randomized and there were 3 postrandomization exclusions from the control group as women became ineligible. It was not clear whether there were any missing data.

Selective reporting (reporting bias)Unclear riskAssessment from published report.

Other biasUnclear riskNo significant differences between groups at baseline on the variables measured, although there were a greater proportion of female children in the control group (63% vs 48%) (it is not clear whether this would be likely to be associated with any between group differences).

 

Other: it was not clear whether possible confounding factors were taken into account. The main outcome was infant sleep and movement. This is likely to have been affected by the use of systemic opioid analgesia during labor . It was not clear whether any women had received opioids.    

Gouchon 2010

MethodsRandomized controlled trial (a computer-generated a randomization list). Mothers were randomized using opaque, sealed envelopes containing the group allocation.


Participants34 Italian women scheduled for elective cesarean delivery using locoregional anesthesia recruited from the maternity ward of Pinerolo Hospital, Turin, Italy and their healthy full term infants.


InterventionsBoth groups: physical assessment, Apgar score, infants dried, wrapped in towel, handed to mother for brief contact and transported to neonatal ward in an incubator for inspection, bath, weight. Mother to OB ward.

Control: baby dressed, taken to mother’s room, mother instructed on how to breastfeed but she could choose whether she wanted to breastfeed or not. Mom could keep baby in her bed, in a crib or in the nursery during the 2-hour observation period.

SSC: same treatment as control, but not dressed; fitted with disposable diaper, cap and wrapped in a warm cloth; placed on mother’s skin between breasts, left covered with cloth, bed sheet, and blanket for approximately 2 hours. Mother instructed about how to breastfeed.

Mean duration of SSC was 82.9 + 45.9 min.


OutcomesNewborn skin temperature using an infrared ray thermometer on the forehead, effectiveness of the first breastfeeding, min postbirth of the first breastfeeding, exclusive or prevalent breastfeeding at hospital discharge and at 3 months postbirth, infant crying and maternal satisfaction with SSC.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskStates mothers were randomized using a computer-generated randomization list.

Allocation concealment (selection bias)Low riskStates opaque, sealed envelopes containing the next allocation were used. The mothers were recruited prenatally, the envelopes were opened by the nurse on the day of surgery.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskNo information provided.

IBFAT scores and infant temperatures were obtained while the infants were held either SSC or dressed so the outcome assessors could not be blind to group assignment for these outcomes.

Incomplete outcome data (attrition bias)
All outcomes
Low risk36 women were randomized, 2 women did not receive their assigned intervention and there were no losses to follow-up. Reasons were provided for why the 2 mothers did not receive their allocated intervention. Data were analyzed on 17 mothers in the SSC group and 17 in the control group.

Selective reporting (reporting bias)Low riskAll outcomes were listed under the aims of the study. Numerical results for all outcomes, except infant crying were reported.

Other biasHigh riskInfants in both groups were bathed in the neonatal ward before being returned to their mothers. Bathing (as well as SSC) would influence the temperature outcomes. Mothers in both groups were instructed about how to breastfeed.

Hales 1977

MethodsRandomized controlled trial.


Participants60 healthy full term infants randomized into 3 groups.


Interventions1) Control group = glance at babies immediately after delivery, swaddled infants brought to bedside at 12 hours postbirth, then daytime rooming-in.
2) Early contact group = 45 min of SSC immediately postbirth, daytime rooming-in. 3) Delayed contact group = 45 min of SSC at 12 hours postbirth, daytime rooming-in.


OutcomesObservation of maternal affectionate, proximity maintaining and caretaking behavior at 36 hours postbirth.


NotesStudy was done with low-income, urban, breastfeeding primipara in Guatemala city.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk“Twenty mothers were randomly assigned to each of three groups”.

 

Allocation concealment (selection bias)Unclear risk“Twenty mothers were randomly assigned to each of three groups”.

 

Blinding (performance bias and detection bias)
All outcomes
Unclear riskIt was not clear whether the lack of blinding would affect maternal or clinician behavior. It was stated that observation of maternal behavior was carried out by an investigator who was not aware of group assignment.

Incomplete outcome data (attrition bias)
All outcomes
Low risk60 mothers were randomized and followed up at 36 hours. It appeared that  all women were accounted for, although denominators were not provided in the results tables.                                                  

Selective reporting (reporting bias)Unclear riskAssessment from brief study report.

Other biasUnclear riskThere was little information on study methods. It was stated that groups were comparable at baseline although it appeared that groups were not balanced in terms of infant sex; in the 2 intervention groups 14/20 and 13/20 babies were female compared with 7/20 in the control group.

Huang 2006

MethodsRandomized controlled trial, states random digit table on page 43.


Participants78 mothers who had spinal anesthesia for cesarean birth and their full term infants who were hypothermic (body temperature < 36.5 ºC) postbirth.


InterventionsControl group = infants received routine care while under a radiant warmer.

KC group = infants were placed skin-to-skin between their mother's breasts after the mothers felt comfortable approximately 50 min postcesarean birth and covered with blankets. The duration of KC was 30 min. The infant's rectal temperature was taken after 30 min of KC and then every hour until the temperature was back to normal. If the rectal temperature was < 36.5, the infant was placed under a radiant warmer. The researchers did not state how many KC infants had rectal temperatures < 36.5 at the end of the intervention.


OutcomesThe infant's rectal temperature was taken 30 min after KC started or after radiant warmer care. Infant temperature was recorded hourly starting 1 hour until 6 hours postbirth and was plotted on a graph.The number and % of infants in each group who reached normal body temperature after 4 hours was listed.


NotesStudy was conducted in Taiwan.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAbstract states "randomized control trial." States random digit table on page 43.

Allocation concealment (selection bias)Unclear riskNo information provided other than random digit table.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskNo information provided.

Incomplete outcome data (attrition bias)
All outcomes
Low risk86 mothers agreed to participate in the study but data were analyzed for only 78 infants. 2 mothers withdrew because they were tired. 4 mothers felt cold and began to shiver. The other 2 mothers exhibited tachypnea. It was not clear which of these mothers were in the KC and control groups.

Selective reporting (reporting bias)Unclear riskData collected on the % of infants in each group who achieved normal body temperature (36.5 ºC.) after 1-6 hours and plotted on a graph, numerical data provided for only hour 4.

Other biasHigh riskInfants in the KC group weighed significantly more (30.72 + 3.93) than those in the control group (28.08 + 4.28) (P < .01)

Kastner 2005

MethodsRandomized controlled trial, no other information provided.


Participants57 vaginally delivered mothers intending to breastfeed and their healthy full term infants.


InterventionsIn the usual care condition the mother and her infant remained together for 20 min. immediately postbirth. Then they were separated for routine infant care (weighing, measuring). Next the infant was dressed and returned to the mother for the first breastfeeding.

In the SSC group the mother and infant spent the first hour postbirth alone and undisturbed as much as possible.


Outcomes4 mother-child relationship scales (maternal physical contact, maternal speech/verbal communication, maternal breastfeeding, child to mother contact), infant attempts to reach the breast and grasp the nipple independently. 3 additional scales evaluating maternal fatigue and anxiety, partner support, maternal medication administration.


NotesStudy was conducted in Munich, Germany.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskSummary states that the study was "prospective and randomized." No further information provided.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding (performance bias and detection bias)
All outcomes
Low riskMothers were told that the study involved "observation of healthy newborns and their behavior in the first hour after childbirth as well as their further development in the early weeks of the child's life," not the true purpose of the study.

The 2 outcome assessors who evaluated the video recordings were "blind to the group division of the mother-child pairs," according to the research report.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskAt 3-5 days postbirth, 4/31 infants were missing from the intervention group and 5/26 for the control group; at 5-6 weeks postbirth 7/31 infants were missing from the intervention group and 9/26 from the control group. No reasons were provided for participant attrition.

No standard deviations were reported for mean outcome data on scales 1-4.

Selective reporting (reporting bias)Unclear riskNo numerical data were reported for scales 5-7 although the results were stated as insignificant.

Other biasUnclear riskThe researchers acknowledge that video recording is a "disturbance" to the mother. The amount that video recording might have altered the mother's behavior is unknown.

Khadivzadeh 2008

MethodsRandomized controlled trial. The randomization method was not described.


Participants92 primigravid mothers and their healthy full term infants delivering at Om-ol-banin Hospital in Mashhad, Iran


InterventionsControl: the infant was shown briefly to the mother before being placed under a radiant warmer for routine care (physical assessment, vitamin K injection). The infant was then given to the mother wrapped in a blanket after the perineal or episiotomy repair and the mother was encouraged to start breastfeeding.

SSC: the infant was placed prone between mother’s breasts skin-to-skin immediately postbirth. The infant's head was covered with a hat, and the back with a warm blanket. The infant was moved next to the breast and the mother was encouraged to start breastfeeding as soon as the infant displayed prefeeding behaviors. The Apgar score was assessed during SSC; all routine care was delayed until the infant was 2 hours postbirth.


OutcomesDuration from birth until the first breastfeeding, number of infants breastfeeding during the first 30 min. postbirth, success and duration of the first breastfeeding, maternal feelings about SSC during the first 2 hours postbirth.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskStates randomized controlled trial at the beginning of the Methods section. No further information provided.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskNo information provided. However, IBFAT scores were obtained during the first breastfeeding when the infants were either SSC or wrapped in a blanket so the outcome assessors could not be blind to group assignment for this outcome.

Incomplete outcome data (attrition bias)
All outcomes
Low riskThe trial included 92 mothers and their infants, 47 received SSC and 45 received routine care. Data were analyzed on all the participants.

Selective reporting (reporting bias)Unclear riskNumerical data were reported for all the outcomes identified in the results section.

Data were also collected on maternal attachment and anxiety, results were reported elsewhere.

Other biasHigh riskSSC infants were placed prone between their mother's breasts immediately postbirth and then left undisturbed. The control infants received a number of co-interventions (physical assessment, vitamin K injection) which could have been disruptive to their ability to breastfeed.

Mazurek 1999

MethodsRandomized controlled trial.


Participants66 healthy full term infants and their mothers (mean GA 39 weeks).


InterventionsAfter birth all infants were dried, cord blood PH was drawn and measurements were taken.
1) SSC group = the infant was placed in their mother's arms SSC 6-8 min postbirth and both were covered with a sheet. SSC continued for 75 min. 2) Mother's arms group = the infant was wrapped in a blanket and given to the mother to hold for 75 min. 3) Control group = the infant was wrapped and kept at a distance from their mother in the same room.


OutcomesCrying time, blood glucose, HR and respiratory rate at 75 min postbirth, blood PH, skin thigh temperature.


NotesStudy was done in Warsaw, Poland.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskWomen were divided into “three randomised groups”. Methods not described.

Allocation concealment (selection bias)Unclear riskMethods not described.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskThere was no mention of blinding and some of the outcomes (infant crying behavior) and temperature may have been susceptible to observer bias. Other outcomes may not have been affected by lack of blinding (arterial blood gases).

 

Incomplete outcome data (attrition bias)
All outcomes
Low risk66 women were randomized and all appeared to be accounted for in the results and analyses; the period of follow-up was short (75 min). It was not clear whether there was any missing data.                                                           

Selective reporting (reporting bias)Unclear riskLarge number of data collection points and measures. Assessment from published report only.

Other biasUnclear riskBaseline imbalance not apparent.

There was little information on study methods. Assessment of risk of bias was from abstract and translation notes (original paper not in English).

McClellan 1980

MethodsRandomized controlled trial (table of random numbers).


Participants40 healthy full term infants born by repeat cesarean section (spinal anesthesia).


Interventions1) Control group = visual contact < 5 min, holding the swaddled infant for 10-20 min in the nursery during the first 12 hours postbirth, then rooming-in. 2) Early contact group = visual contact for 5 to 15 min, SSC for the first hour in the recovery room, then rooming-in.


Outcomes1) Neonatal Perception Inventory. 2) Postnatal research inventory. 3) Observation of maternal behavior.
All variables measured on postpartum day 1 or 2 and 28-32 days postbirth.


NotesStudy was done with middle-income, multipara in the USA.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskStated that a table of random numbers was used to ensure “no systematic bias” but then went on to say that “if the woman did not meet the characteristics of the population, she was replaced by the next woman who qualified, until there were 20 mothers in each group”

It was not clear at what point randomization occurred or how many women were randomized and excluded postrandomization and then replaced.

Allocation concealment (selection bias)High riskWomen were “randomly assigned”, “if the woman did not meet the characteristics of the population, she was replaced by the next woman who qualified, until there were 20 mothers in each group”.

It was not clear at what point randomization occurred or how many women were randomized and excluded postrandomization and then replaced.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskWomen would be aware of which group they were in and would be aware of observations. Clinical staff would be aware of group assignment. It was stated that the nurses carrying out observations were unaware of group assignment.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk It was not clear how many women were randomized and then later excluded and replaced. 40 women received the intervention and all seemed to be accounted for in the analysis. It was not clear if there was any missing data.                                                          

Selective reporting (reporting bias)Unclear riskAll outcomes specified in the introduction were reported on, it is not clear if other outcomes were measured, we did not have access to the study protocol.                 

Other biasUnclear riskGroups appeared similar at baseline.

It was not clear what the mean scores reported represented, e.g. a mean mother and infant behavior score (from observation) – whether a higher score was more positive or what was being recorded. The measure is referenced but without knowing how scoring works it is not easy to interpret the results.

Mizuno 2004

MethodsRandomized controlled trial.


Participants60 healthy full term infants > 37 weeks' gestation and their mothers.


Interventions1) SSC group = extensive SSC (M = 63.7 min) immediately postbirth with effective suckling. Then mothers and infants were separated for 24 hours and infants were fed formula. After 24 hours rooming-in with q3hr breastfeedings. 2) Control group = first mother-infant contact 24 hours postbirth then rooming-in and q3hr breastfeedings. Midwives assisted both groups with the first breastfeeding.


OutcomesFrequency of mouthing movements with exposure to own mother's milk, another mother's milk, formula, orange juice, distilled water at 1 and 4 days of age. Difference in frequency of mouthing movements between mother's milk and another mother's milk at 1 and 4 days of age, duration of breastfeeding.


NotesStudy was done in Chiba, Japan.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization process was not described.

Allocation concealment (selection bias)Unclear risk“randomly assigned”.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskMain outcome was baby reaction to various odor stimuli, it is unlikely that lack of maternal blinding would have affected this. Staff providing care would be aware of group assignment and it was not clear whether those carrying out infant observations were aware of group assignment, it was stated that interviewers collecting longer term breastfeeding outcome data were blind to group allocation.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk60 women were included, 30 in each group, 2 women were lost from the control group. Denominators were not provided on tables or figures, so it was not clear how many women were followed up after hospital discharge.

Selective reporting (reporting bias)Unclear riskAssessment carried out from published report. The validity of the main outcome measure and the method of observing infant response were not clear.                    

Other biasUnclear riskNo baseline imbalance between groups reported.

Moore 2005

MethodsRandomized controlled trial (computerized minimization technique).


Participants20 healthy full term infants > 37 weeks' gestation and their mothers.


Interventions1) SSC group = infant placed prone SSC on mothers abdomen. Baby moved to warmer after cord cut. Then infant placed prone on mother's bare chest between breasts. Moved to cross cradle nursing position when infant displayed early hunger cues (M = 99.5 min of SSC) Breastfeeding assistance provided by researcher. 2) Control group = infant shown briefly to mother and moved to warmer. Then infant swaddled in blankets and held by mother. Moved to cross cradle nursing position when infant displayed early hunger cues. Breastfeeding assistance provided by researcher.


OutcomesSuccess of the 1st breastfeeding, time of effective breastfeeding, body weight change day 14 postbirth, number of breastfeeding problems in the 1st postpartum month, mother's perception of the adequacy of her milk supply, maternal parenting confidence, breastfeeding status 1 month postbirth.


NotesStudy was done in the USA with primarily Caucasian, married, college-educated primipara.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated minimization process.

Allocation concealment (selection bias)Low riskAssignment by computer minimization process.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskThis was an unblinded study. Participants were aware of group assignment. The chief investigator provided some of the postbirth care (including help with breastfeeding) and collected some of the outcome data.

Incomplete outcome data (attrition bias)
All outcomes
Low risk20 of the 23 women randomized were followed up.

Selective reporting (reporting bias)Unclear riskAll outcomes appear to have been reported. Assessment from published trial report.

Other biasLow riskGroups appeared similar at baseline (randomization by minimization technique).

Nolan 2009

MethodsRandomized controlled trial (mothers were randomly assigned to the Nursing Intervention to Minimize Maternal-Infant Separation (NIMS) or control group by a coin flip).


Participants50 women scheduled for a repeat cesarean delivery with regional anesthesia and their healthy full term infants.


InterventionsControl: standard/usual postoperative OB care was unstructured. The mothers typically had brief physical or no contact with their infants until they were admitted to the obstetric postanesthesia care unit. Breastfeeding was sometimes included. SSC was not routinely encouraged in the PACU.

Intervention: a minimum of 10-15 min of SSC was offered in the PACU as part of a NIMS protocol which included a number of co-interventions such as intra-/postoperative environmental manipulation to maintain a maternal-infant spatial distance of less than 8ft. with uninterrupted maternal visual and auditory contact, en face presentation at birth, and intraoperative cheek-to-cheek contact for a minimum of 3 min. The NIMS intraoperative protocol could be considered a sensory intervention which is a preamble to SSC in a situation where it is impossible to implement SSC immediately postbirth.

The mean duration of SSC was 33 + 13 min.


OutcomesMaternal pain, anxiety, infant respiratory rate, temperature, salivary cortisol, breastfeeding initiation in the PACU, breastfeeding at hospital discharge and at 4 weeks postbirth, maternal perception of childbirth.


NotesThis study took place in the US.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskMothers were randomly assigned to the NIMS or control group by a coin flip.

Allocation concealment (selection bias)Low riskThe researchers obtained informed consent from interested mothers when they arrived on the obstetrics ward and then randomly assigned the mothers to groups by a coin flip.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskThe nurses who provided usual care to the control mothers were unfamiliar with the NIMS protocol.

No information was provided about whether the research nurse who conducted the medical record reviews, and obtained salivary cortisol samples was blind to participant group assignment.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk72 mothers were recruited to participate in the study. 23% of the mothers did not receive their assigned intervention for various reasons such as unplanned general anesthesia, infant medical complications, staffing issues. There were 25 mother infant pairs in each group. 30% (n = 15) of the mothers has some missing pain scores. The number of missing pain scores did not differ significantly between groups. 30% (n = 15) of the infants had some missing temperature and salivary cortisol data. More infants in the NIMS group had missing salivary cortisol data. The number of missing infant temperature data did not differ significantly between groups. 36% (n = 18) of the infants had missing respiratory rate data. The amount of missing respiratory data did not differ significantly between groups.

Selective reporting (reporting bias)Low riskNumerical data were provided for all outcomes.

Other biasHigh riskThis study was included with considerable caution due to the following issues.

Infants in the SSC group weighed significantly more (3585.40 + 546.5 g) than those in the control group (3299.60 + 374.7 g) (P < .04).

On admission to the PACU, before SSC was initiated, infants in the NIMS group had significantly higher salivary cortisol levels (M = 3.27 + 1.43) than infants in the control group (M = 1.90 + 0.72).

There were a number of co-interventions in this study. Therefore, it is impossible to disentangle the effects of SSC from those of the other interventions.

Usual care was unstructured. The exact conditions which the NIMS protocol was being compared.to are unknown.

Punthmatharith 2001

MethodsRandomized controlled trial (computerized minimization technique).


Participants196 healthy full term 37-42 weeks' gestation infants and their mothers.


InterventionsAll infants received standard care for the 1st 30-60 min postbirth. After the cord was clamped they were shown briefly to mom and moved to a warmer. 1) SSC group = beginning 60 min postbirth infants received (M = 30 min) of SSC. Mothers were encouraged to breastfeed on infant demand. Infants and mothers transferred to the postpartum unit at 120 min postbirth for 24 hour rooming-in. Mothers encouraged to provide SSC 15-30 min before each breastfeeding. No other fluids given to infants. 2) Control group = swaddled infant given to mom after episiotomy repair and they were transferred together to the recovery room for 2 hours, then to postpartum for 24 hour rooming-in. Mothers encouraged to breastfeed on infant demand. Cup feeding was encouraged if the infant required supplementation.


OutcomesObservation of maternal affectionate behaviors during a breastfeeding at 36-48 hours postbirth, 4 subscales of the maternal-infant bonding questionnaire (attention/connection to the infant, preparation for nurturing the infant, role of mother, breastfeeding the infant) at 36-48 hours and week 4 postbirth, Mother's perception of the adequacy of her milk supply, and breastfeeding status 36-48 hours and week 4 postbirth, infant weight day 2 and 1 month postbirth.


NotesStudy was done in a Baby Friendly Hospital in Songkhla, Thailand.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskSequence generation was by computerized minimization method with stratification for 10 factors including parity, age, SES, medication, ward, planned duration of breastfeeding, previous breastfeeding, experience, infant weight and sex.

 

Allocation concealment (selection bias)Low riskComputerized minimization method but no clear description of what happened at the point of randomization.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskMothers would be aware of group assignment and it was stated that because of lack of privacy and cultural factors mothers might feel reluctant to accept the intervention. It was not clear whether there was an attempt to blind staff or outcome assessors and the impact of lack of blinding is not clear.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk195 women were randomized and 167 remained available to follow up. Loss was balanced across groups.

Selective reporting (reporting bias)Unclear riskAssessment from unpublished thesis.

Other biasLow riskGroups appeared comparable at baseline (stratified).

Recruitment was at convenient times, so the sample may not have been representative of the population.

Shiau 1997

MethodsRandomized controlled trial (computerized minimization technique).


Participants58 healthy full term infants and their mothers randomized into 1 of 2 groups 0-4 hours postvaginal or cesarean birth.


Interventions1) KC group = mothers began SSC at 4 hours postbirth and held their infants in SSC 8 hours daily for 3 days. Breastfeeding based on infant hunger cues during the day and every 4 hours at night. 2) Control group = began breastfeeding 24 hours postbirth. Mothers fed their infants every 4 hours in the nursery.


Outcomes1) Mean maternal state anxiety. 2) Mean score on 6 point breast engorgement scale. 3) Chest circumference. 4) Breastfeeding status day 3 and 28 postbirth. 5) Breast milk maturation. 6) Breastfeeding duration.


NotesStudy was done with married primipara and multipara in Taiwan. The researcher provided all nursing care to the SSC group during the day.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskBy computerized minimization technique taking account of gestational and maternal age, infant sex, type of birth, maternal education and previous BF experience.

Allocation concealment (selection bias)Low riskComputerized assignment.

Blinding (performance bias and detection bias)
All outcomes
High riskThere was no blinding in this study and care for the intervention group was provided by the investigator who also gave advice on breastfeeding and collected outcome data. The control group received care from different staff. It is likely that other aspects of care as well as SSC would be different between the 2 groups.

Incomplete outcome data (attrition bias)
All outcomes
Low risk58 mother infant pairs were randomized and all were accounted for in the analyses although there was some missing data for some outcomes.    

Selective reporting (reporting bias)Unclear riskAssessment from unpublished dissertation.

Other biasUnclear riskNo baseline imbalance apparent.

The fact that care for the intervention and control groups was  provided by different staff may be a serious source of bias in this study.

Sosa 1976a

MethodsRandomized controlled trial (random numbers in sealed envelopes).


Participants60 healthy full term infants and their mothers randomized immediately after delivery.


Interventions1) Experimental group = mothers held their infants in SSC for 45 min after the episiotomy repair. They were encouraged to breastfeed. 2) Control group = infants were separated from their mothers for 12 hours.


Outcomes1) Mean duration of breastfeeding. 2) Episodes of illness, growth and development, mortality.


NotesStudy was done with poor, urban primipara from the marginal area of Guatemala city.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk“Assignment of mother-infant pairs.... was made from random numbers..”

Allocation concealment (selection bias)Unclear riskAllocations were concealed in sealed envelopes which were opened immediately after delivery.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskAttempts to blind mothers, staff and outcome assessors were not mentioned. Mothers would be aware of allocation, staff were also likely to have been aware of treatment group and may have altered other aspects of treatment and outcome assessors accompanied the mothers home from hospital so may well have been aware of group allocation.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk60 women. Denominators for longer tem outcomes were not specified so it is not clear how many women remained available to follow-up at each data collection point.

Selective reporting (reporting bias)Unclear riskAssessment made from published reports only.  In this study the intervention appeared to have a negative effect on breastfeeding duration this was explained by possibly different populations in the control and intervention groups (although randomization should have controlled for this).          

Other biasUnclear riskThere was some imbalance in the socio-economic background of women although this was not consistent across study sites.

Little information was provided on study methods.

Women were followed up for 9 months or 1 year. Duration of breastfeeding was an outcome. It is not clear whether any women were still breastfeeding at the final data collection point. No SDs were provided for continuous variables so some findings were difficult to interpret.

Sosa 1976b

MethodsRandomized controlled trial (random numbers in sealed envelopes).


Participants68 healthy full term infants and their mothers randomized immediately after delivery.


Interventions1) Experimental group = mothers held their infants in SSC for 45 min after the episiotomy repair. They were encouraged to breastfeed. 2) Control group = infants were separated from their mothers for 12 hours.


Outcomes1) Mean duration of breastfeeding. 2) Episodes of illness, growth and development, mortality.


NotesStudy was done with poor, urban primipara from the marginal area of Guatemala city.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk“Assignment of mother-infant pairs.... was made from random numbers..”

Allocation concealment (selection bias)Unclear riskAllocations were concealed in sealed envelopes which were opened immediately after delivery.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskAttempts to blind mothers, staff and outcome assessors were not mentioned. Mothers would be aware of allocation, staff were also likely to have been aware of treatment group and may have altered other aspects of treatment and outcome assessors accompanied the mothers home from hospital so may well have been aware of group allocation.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk68 women. Denominators for longer tem outcomes were not specified so it is not clear how many women remained available to follow-up at each data collection point.

Selective reporting (reporting bias)Unclear riskAssessment made from published reports only.             

Other biasUnclear riskThere was some imbalance in the socio-economic background of women although this was not consistent across study sites.

Little information was provided on study methods.

 

Women were followed up for 9 months or 1 year. Duration of breastfeeding was an outcome. It is not clear whether any women were still breastfeeding at the final data collection point. No SDs were provided for continuous variables so some findings were difficult to interpret.

Sosa 1976c

MethodsRandomized controlled trial (random numbers in sealed envelopes).


Participants40 healthy full term infants and their mothers randomized immediately after delivery.


Interventions1) Experimental group = mothers held their infants in SSC for 45 min after the episiotomy repair. They were encouraged to breastfeed. 2) Control group = infants were separated from their mothers for 24 hours.


Outcomes1) Mean duration of breastfeeding. 2) Episodes of illness, growth and development, mortality.


NotesStudy was done with poor, urban primipara from the marginal area of Guatemala city.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk“Assignment of mother-infant pairs.... was made from random numbers..”

Allocation concealment (selection bias)Unclear riskAllocations were concealed in sealed envelopes which were opened immediately after delivery.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskAttempts to blind mothers, staff and outcome assessors were not mentioned. Mothers would be aware of allocation, staff were also likely to have been aware of treatment group and may have altered other aspects of treatment and outcome assessors accompanied the mothers home from hospital so may well have been aware of group allocation.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk40 women. Denominators for longer tem outcomes were not specified so it is not clear how many women remained available to follow-up at each data collection point.

Selective reporting (reporting bias)Unclear riskAssessment made from published reports only.             

Other biasUnclear riskThere was some imbalance in the socio-economic background of women although this was not consistent across study sites.

Little information was provided on study methods.

 

Women were followed up for 9 months or 1 year. Duration of breastfeeding was an outcome. It is not clear whether any women were still breastfeeding at the final data collection point. No SDs were provided for continuous variables so some findings were difficult to interpret.

Svejda 1980

MethodsRandomized controlled trial.


Participants30 healthy full term infants and their mothers.


Interventions1) Control group = held their wrapped infants briefly (< 5 min) during transfer, then 30 min of contact at feedings every 4 hours. 2) Extra contact group = SSC for 15 min beginning 25 min postbirth, then the gowned mothers held their nude infants for 45 min in their rooms, 90 min of contact every 4 hours for feedings.


OutcomesVideotaped affectionate and proximity - maintaining behavior in interaction with the infant, affectionate and caretaking behavior during breastfeeding 36 hours postbirth.


NotesStudy was done with middle-income, primipara in the USA.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskVery little information about study methods provided. Method of sequence generation not described.

 

Allocation concealment (selection bias)Unclear risk“mothers were randomly assigned”. Method not described.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskThe intervention was not explained to women. Staff providing care would be aware of group assignment. There was an attempt to check that the duration of time nurses spent with women was not greater for the intervention group. Outcome data were derived from observations of videotapes with maternal behavior coded by researchers who were described as being blind to group assignments; inter-rater reliability was checked.

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll women were included in the analyses.                                                           

Selective reporting (reporting bias)Unclear riskIt was not clear how scores from observations were calculated and whether women could contribute different numbers of observations.                                               

Other biasUnclear riskIt was stated that the 2 groups were comparable at baseline. Very little information was provided on study methods.

Syfrett 1996

MethodsRandomized controlled trial (computerized minimization technique).


Participants8 healthy late preterm infants 34-36 weeks' gestation, average for GA, Apgars 7 or more, and their mothers.


Interventions1) Control group = 24 min of SSC during the first hour postbirth before randomization to radiant warmer for 3 hours, double wrapped in open bassinet for 3 hours then demand feeding and continuous rooming-in if stable. 2) KC group = 40 min of SSC during the first hour postbirth, transferred to nursery for admission procedures, then continuous SSC (mean 37 hours) and breastfeeding on demand.


OutcomesTemperature, temperature variability, breastfeedings/day, bottle-feedings (ml/day), IV fluids (ml/day), weight loss (g/hr), birthweight lost (%), number of heel sticks, length of stay (total days), breastfeeding duration.


NotesStudy was done in the USA. All nursing care in the KC group was done by the researchers.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk“random assignment.... was done using the minimization technique”. The randomization sequence took account of a relatively large number of stratifying variable and the eventual sample size was only 8 women. (Stratification by GA, race, sex, induction or augmentation, intrapartum analgesia/ anesthesia, maternal magnesium sulphate and previous breast feeding experience.

Allocation concealment (selection bias)Low riskRandomization was carried out 1 hour after birth at admission to the newborn nursery. 1 of the investigators revealed the next allocation in the randomization sequence.

Blinding (performance bias and detection bias)
All outcomes
High riskThis study was at high risk of bias due to the lack of blinding. It was stated that control group women may have been dissatisfied knowing that the intervention group were given more infant contact. The control group and the intervention group were cared for by different staff. The control group received routine care while the intervention groups received special care from the investigators – which included advice on breastfeeding and 5 min pager access to staff as well as advice on SSC. The same nurse investigators also collected outcome data for the SSC group.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk8 infants were involved in this study and all but 1 were followed up for a year.

Selective reporting (reporting bias)Unclear riskAssessment from unpublished thesis. The recruitment, intervention and data collection were carried out by the same (unblinded) investigators.

Other biasHigh riskThis study had a very small sample size that was recruited at times convenient to the investigators over a 10 month period. It is not clear that the sample was representative of the population from which it was drawn. The intervention was delivered by the investigators and included changes to aspects of care other than SSC (e.g. breastfeeding advice). It is difficult to separate the effects of the intervention from the effects of other elements within the package of care.

Thomson 1979

MethodsRandomized controlled trial.


Participants34 healthy full term infants and their mothers.


Interventions1) Control group = held their wrapped infants briefly (< 5 min), subsequent contact at 12-24 hours postbirth, then contact every 4 hours for feedings during the day. 2) Early contact group = held infant in SSC for 15-20 min starting 15-30 min postbirth. Mothers were encouraged to breastfeed, subsequent contact at 12-24 hours postbirth, then contact every 4 hours for feedings during the day.


Outcomes1) Happy maternal reaction to birth. 2) Breastfeeding at hospital discharge. 3) Successful breastfeeding 2 months postbirth.


NotesStudy was done with married, primipara in Canada.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskThe randomization process was not described “the observer randomly assigned the mother-infant pair to a control or to an early-contact group”.

 

Allocation concealment (selection bias)Unclear riskThe process was not described.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskWomen were not told about the study intervention but told that the study was about infant nutrition. It was stated that only delivery room staff caring for women were aware of group assignments, staff thereafter were not made aware of allocation. The person carrying out the randomization also collected delivery room data, but staff collecting other outcome data were described as blind although women may have revealed group status.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk34 women recruited. 4 lost to follow up.  

Selective reporting (reporting bias)Unclear risk1 outcome “Happy maternal reaction to the infant” was assessed by an observer that had carried out the randomization and remained in the delivery room during the intervention.                  

Other biasUnclear riskLittle information on study methods was provided.

Vaidya 2005

MethodsRandomized controlled trial.


Participants110 healthy full term infants and their mothers.


Interventions1) SSC group = the naked infant was placed on the mother's naked chest for 10-15 min within 1 hour of birth. 2) Control group = after immediate newborn care the infants were dressed and given to their mothers or visitors. Both groups were encouraged to initiate breastfeeding.


OutcomesExclusive breastfeeding up to 2-4 and 4-6 months postbirth, started other feedings before 2 months of age.


NotesStudy was done in Kathmandu, Nepal.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk“...some mother-baby pairs were selected randomly and after taking verbal consent were allowed to have skin-to-skin contact.... In the remaining control group, babies after immediate newborn care were dressed as usual”.

Allocation concealment (selection bias)Unclear riskThere was little information about study methods and the method of randomization was not described clearly.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskBlinding was not mentioned, it is likely that all groups were aware of group assignment.

Incomplete outcome data (attrition bias)
All outcomes
High riskIt was stated that 110 women were included in the study and 92 were followed up, the reasons for loss to follow up were not stated. It was not clear where the numbers of women lost to follow up were the same in the control and intervention groups. There was some discrepancy in numbers in different tables; in a table setting out duration of breast feeding by mode of delivery only 60 women were accounted for.

Selective reporting (reporting bias)Unclear riskAssessment from published study report.

Other biasUnclear riskThe sample was not described and it was not clear whether the 2 groups were balanced in terms of parity, mode of delivery, and other potentially important variables.

Very little information about study methods was provided.

Villalon 1993

MethodsRandomized controlled trial.


Participants119 healthy full term infants and their mothers.


InterventionsSSC Group = babies were placed SSC on their mothers immediately postbirth, then dried and given medications. Diapered infants were then placed between their mother's breasts and covered with a blanket. Breastfeeding was initiated or attempted. Babies stayed in contact with their mothers for most of the following 4 hours. Control group = babies were dried, given medications, clothed and taken to the nursery for 4 hours.


OutcomesBreastfeeding at 24 hours, hospital discharge, and 14 days postbirth, maternal parenting confidence, temperature, HR, respiratory rate at 1,2,3 and 4 hours postbirth in a subset of 92 infants.


NotesStudy was done in Coyhaique, Chile. All mothers were Hispanic with mixed parity and education. Temperature, HR and respiratory rate data were obtained from a subset of 96 infants.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskThe randomization process was not described.

Allocation concealment (selection bias)Unclear riskThe randomization process was not described.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskNo blinding of women, clinical staff or observers and outcomes susceptible to response and observer bias.

Incomplete outcome data (attrition bias)
All outcomes
High riskDescribe any loss of participants to follow-up at each data collection point: 119 women randomized.  It appeared that outcome data were available for all women at 24 hours. However, at 14 days data were only available for 65 (54%) of the randomized sample (loss was balanced across groups). There was no ITT analysis for outcomes at 14 days.                                                

Selective reporting (reporting bias)Unclear riskAssessment made from translation notes from published article (protocol not available).                    

Other biasUnclear riskBaseline imbalance not apparent.

 

Other: risk of bias assessment from translation notes. 

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Abdel Razek 2009This quasi-experimental study was conducted in 2 maternal and child health centers in Jordan. The study was conducted on infants receiving immunization injections during their first year of life.

Ali 1981No mention was made regarding whether the early maternal-infant contact was skin-to-skin.

Anisfeld 1983This study was a quasi-randomized trial. Group assignment was by day of the week.

Castral 2008This study took place with stable preterm infants (at least 30 weeks' GA) during a heel lance procedure. All of the infants were located in the intermediary neonatal care unit; 62% of these infants had been transferred from the NICU. Mean birthweight was 1748.8 g for the SSC infants and 1846.2 g for the control group.

Cattaneo 1998This was not a study of early KMC. The median age of enrolment in the study was 10 days postbirth for KMC infants and 8 days postbirth for CMC infants.

Christensson 1998Infants in the control and intervention groups were hypothermic and admitted to the NICU before the study began.

Darmstadt 2006This was not a study of early SSC. The intervention was a community mobilization and behavior change communication program aimed at increasing the acceptability of skin-to-skin care for mothers who deliver at home in rural Uttar Pradesch, India.

Durand 1997Not a randomized trial, participants self-selected into the experimental or control group based on their desire to breast or bottle feed.

Erlandsson 2007This was a study of skin-to-skin care with the father after cesarean birth.

Feldman 2003Study was not an RCT. KC infants were recruited at 1 hospital and control infants from another hospital. Infants were cared for concurrently at the 2 hospitals. Families were recruited to participate several days to several weeks postbirth. All infants were in the NICU. Mean GA - 30.65 weeks.

Ferber 2008This study was conducted on preterm infants in the NICU.

Gardner 1979No information was provided about whether infants were randomized to SSC (group 1) or standard care in a Kreisselman warmer bed (group 2). No means and standard deviations were provided for the outcome variable rectal temperature at 17 min postbirth.

Gathwala 2008This was a study of KMC for preterm and low birthweight infants in the NICU. KMC was initiated at a mean age of 1.72 + 0.45 days of age.

Gomes-Pedro 1984The early contact in the intervention group was not skin-to-skin.

Gray 2000This was not a study of early SSC. Infants were between 33 and 55 hours postnatal age at study entry.

Gray 2002Infants were between 40 and 44 hours postnatal age at study entry.

Grossman 1981A questionable quasi-randomization procedure was used - the experimental treatment and time are confounded. No mention was made regarding whether the early contact was skin-to-skin.

Hill 1979The study was described as "experimental" with 50 infants per group but the author does not state that infants were randomized to groups. Study compared swaddled holding (not SSC) by the mother or father to a heated transporter.

Ibe 2004In the KMC group, infants were dressed in cotton vests and caps and placed between their mother's breasts. The study was not an RCT - infants served as their own controls and alternated between KMC and incubator care. Infants were recruited between 24 hours to 30 days of age.

Johanson 1992In the KC group "the baby was placed under the mother's clothes on her chest. If the clothing alone was considered insufficient, the baby was swaddled in 1 of the labor room blankets and then kept immediately against the mother" (p 860). The full term data were not reported separately; instead they were combined with preterm data in the analyses.

Johnson 1976No mention was made regarding whether the early maternal-infant contact was skin-to-skin.

Kadam 2005Study was conducted in a level 3 NICU in Mumbai, mean age of the infants at enrolment was 3.2 days, range 1-8 days, mean GA of the KC infants was 33.3 weeks.

Karlsson 1996Not a randomized trial; a descriptive study.

Klaus 1972The early contact in the intervention group was not skin-to-skin.

Kontos 1978This study was not a randomized trial. Mothers who chose to room in and those who did not were alternately assigned to early SSC or usual care. No means or standard deviations were provided for the attachment summary score or individual attachment behaviors.

Lindenberg 1990No mention was made regarding whether the early maternal-infant contact was skin-to-skin.

Ludington-Hoe 2004This was not a study of early SSC. SSC began M =17.82 days postbirth. All infants were in the NICU.

Ludington-Hoe 2006This study was conducted on preterm infants (mean GA 30.8 + 1.4 weeks SSC group, 30.8 + 1.1 weeks control group) in the NICU. Mean age at the time of the study was 11.6 + 5.1 days SSC group, 12.0 + 12 days control group.

Marin 2010The pediatricians, rather than the mothers, were randomly assigned to whether or not they would provide early SSC immediately postbirth.

Mikiel-Kostyra 2002In this study infants were not randomly assigned to groups. Information on the care of 11,973 newborn infants from birth to hospital discharge was collected in 427 maternity wards using a standardized questionnaire. Then a subset of 9612 newborns was created. Then 1923 participants (20% of the subset) were randomly selected by systematic sampling of every 5th case to complete a follow-up questionnaire.

Miles 2006This study was conducted on preterm infants < 32 weeks' GA in 2 NICUs.

Nagai 2010This study was excluded as both groups received SSC in a setting where SSC had already been introduced as standard care; earlier and later SSC were compared. It was intended that the "early" SSC group would begin SSC within 24 hours of the "later" SSC group. In fact there was considerable overlap between the 2 groups and results are difficult to interpret.

Neu 2010This was not a study of early SSC. It is a study of preterm birth (mean GA at birth 33 weeks) in NICU. Women were recruited to participate within 1 month of the birth.

Ohgi 2002This was a non-randomized intervention study of infants who received KC compared to a historical comparison group of infants who did not receive KC. Also KC was initiated 1-3 days postbirth.

Okan 2010This was not a study of early SSC. The infant's mean postnatal age at the time of the intervention hypothesized to decrease pain from a heel lance procedure was 33.1 + 5 hours postbirth.

Ottaviano 1979No mention was made regarding whether the early maternal-infant contact was skin-to-skin.

Ramanathan 2001This study took place in the NICU. Mean GA of the infants was 31.5 weeks.

Roberts 2000This was not a study of early KMC. SSC was started median = 11.8 days postbirth. Median GA was 30.4 weeks in the KMC group; 30.9 weeks in the control group.

Rojas 2001This was a study of preterm infants who were < 1500 grams.

Salariya 1978No mention was made regarding whether the early maternal-infant contact was skin-to-skin.

Sloan 2008This was a study of community-based KMC in rural Bangladesh. Half of 42 unions in 2 Bangladesh divisions were randomly assigned to community-based KMC.

Suman 2008This study enrolled low birthweight infants (< 2000 grams) in a Level III NICU.

Taylor 1979The early contact in the intervention group was not skin-to-skin.

Taylor 1985The early contact in the intervention groups was not skin-to-skin.

Taylor 1986Not a randomized trial, a descriptive study. The early contact in the intervention group was not skin-to-skin.

Tessier 2009This study was conducted with preterm infants (mean GA KMC group 33.6 + 2.5 weeks, control group 33.9 + 2.7 weeks). The infants were all < 2000 grams. The median age for study eligibility was 4 days in the KMC group and 3 days in the control group.

Thukral 2010Not enough information was provided in the research abstract to be able to evaluate the study for methodological quality.

Velandia 2010In this study all infants received early SSC; following cesarean SSC with mothers was compared with SSC with fathers.

Wimmer 1982No standard deviations provided for breastfeeding duration.

Worku 2005This was not a study of late preterm infants. The mean GA was 32.45 weeks KMC and 31.59 weeks CMC infants. The mean birthweight was 1514.8 g (range 1000-1900 g) for KMC and 1471.8 g (range 930-1900 g) for CMC infants. 58% of the KMC and 52% of CMC infants were on IV fluids and 34% of the KMC and 37% of the CMC infants were on oxygen through nasopharyngeal catheter. In addition, these infants experienced significant morbidity; 22.5% of the KMC infants and 38% of the CMC infants died during the study period. Infants were randomly assigned using a list of random numbers to conventional care (n = 61, overhead lamp warmers or a heated room, oxygen therapy, breast, tube, cup or mixed feedings) or early KMC (n = 62) starting during the first 24 hours of life (mean age 10 h KMC, 9.8 CMC).

 
Characteristics of ongoing studies [ordered by study ID]
Keshavarz 2010

Trial name or titleSkin to skin contact with or without music and maternal state anxiety.

MethodsRandomized (single blind) trial.

ParticipantsHealthy Iranian women 20-40 years with term, singleton pregnancy with cesarean section under spinal anesthesia. No history of neonatal death.

InterventionsSkin to skin contact for 30 minutes with music.

OutcomesMaternal state anxiety.

Starting dateJuly 2009.

Contact informationMaryam Keshavarz keshavarz@iums.ac.ir m-keshir@yahoo.com

NotesInformation from a trial registration.

 
Comparison 1. Skin-to-skin versus standard contact healthy infants

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Breastfeeding 1 month to 4 months postbirth13702Risk Ratio (M-H, Random, 95% CI)1.27 [1.06, 1.53]

 2 Duration of breastfeeding in days7324Mean Difference (IV, Random, 95% CI)42.55 [-1.69, 86.79]

 3 SCRIP score first 6 hours postbirth131Mean Difference (IV, Fixed, 95% CI)2.88 [0.53, 5.23]

 4 SCRIP score first 6 hours in newborns below 1800 g birthweight113Mean Difference (IV, Fixed, 95% CI)4.92 [-1.67, 11.51]

 5 Blood glucose mg/dL and mmol/L at 75-90 minutes postbirth294Mean Difference (IV, Fixed, 95% CI)10.56 [8.40, 12.72]

 6 Infant axillary temperature 90 minutes to 2 hours postbirth3Mean Difference (IV, Fixed, 95% CI)Totals not selected

 7 Exclusive breastfeeding at hospital discharge257Risk Ratio (M-H, Fixed, 95% CI)0.99 [0.66, 1.47]

 8 Breastfeeding status day 28 to 1 month postbirth3245Mean Difference (IV, Random, 95% CI)0.86 [-0.73, 2.44]

 9 Exclusive breastfeeding up to 3-6 months postbirth3149Risk Ratio (M-H, Fixed, 95% CI)1.97 [1.37, 2.83]

 10 Breastfeeding 1 year postbirth262Risk Ratio (M-H, Fixed, 95% CI)6.19 [0.82, 46.78]

 11 Success of the first breastfeeding (IBFAT score)254Mean Difference (IV, Fixed, 95% CI)1.79 [0.24, 3.35]

 12 Successful first breastfeeding (IBFAT score 10-12 or BAT score 8-12)3315Risk Ratio (M-H, Random, 95% CI)1.36 [0.95, 1.95]

 13 Suckled during the first 2 hours postbirth188Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.83, 1.35]

 14 Mean variation in maternal breast temp. 30-120 minutes postbirth1132Mean Difference (IV, Fixed, 95% CI)0.60 [0.34, 0.86]

 15 Breast engorgement - pain, tension, hardness 3 days postbirth2131Std. Mean Difference (IV, Fixed, 95% CI)-0.41 [-0.76, -0.06]

 16 Heart rate 75 minutes to 2 hours postbirth3183Mean Difference (IV, Random, 95% CI)-3.05 [-7.84, 1.75]

 17 Respiratory rate 75 minutes - 2 hours postbirth4215Mean Difference (IV, Random, 95% CI)-3.12 [-6.61, 0.37]

 18 Infant did not exceed parameters for stability131Risk Ratio (M-H, Fixed, 95% CI)10.83 [1.63, 72.02]

 19 Transferred to the neonatal intensive care unit131Risk Ratio (M-H, Fixed, 95% CI)1.44 [0.15, 14.29]

 20 Infant body weight change (grams) day 14 postbirth243Mean Difference (IV, Fixed, 95% CI)-6.00 [-175.60, 159.61]

21 Infant weight gain per kilogram per day (in grams)00Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 22 Infant hospital length of stay in hours242Mean Difference (IV, Random, 95% CI)-95.30 [-368.50, 177.89]

 23 Not crying for > 1 minute during 90 minutes129Risk Ratio (M-H, Fixed, 95% CI)12.86 [1.91, 86.44]

 24 Amount of crying in minutes during a 75-minute observation period144Mean Difference (IV, Fixed, 95% CI)-8.01 [-8.98, -7.04]

 25 PCERA Maternal positive affective involvement and responsiveness 12 months postbirth161Mean Difference (IV, Fixed, 95% CI)1.90 [-1.14, 4.94]

 26 PCERA Dydadic mutuality and reciprocity 12 months postbirth161Mean Difference (IV, Fixed, 95% CI)1.30 [0.24, 2.36]

 27 Maternal pain 4 hours postcesarean birth135Mean Difference (IV, Fixed, 95% CI)-1.38 [-2.79, 0.03]

 28 Mother's most certain preference for same postdelivery care in the future1199Risk Ratio (M-H, Fixed, 95% CI)2.82 [2.08, 3.82]

 29 Maternal state anxiety day 3 postbirth156Mean Difference (IV, Fixed, 95% CI)-5.00 [-9.00, 1.00]

 30 Maternal parenting confidence at 1 month postbirth120Mean Difference (IV, Fixed, 95% CI)5.60 [-6.24, 17.44]

 31 Breastfeeding 1 month to 4 months post birth: Sensitivity analysis12642Risk Ratio (M-H, Random, 95% CI)1.31 [1.16, 1.48]

 32 Duration of breastfeeding in days: Sensitivity analysis6264Mean Difference (IV, Random, 95% CI)63.73 [37.96, 89.50]

 33 Heart rate 75 minutes to 2 hrs post birth: Sensitivity analysis294Mean Difference (IV, Fixed, 95% CI)-5.77 [-7.43, -4.11]

 34 Respiratory rate 75 minutes to 2 hours post birth: Sensitivity analysis3126Mean Difference (IV, Fixed, 95% CI)-4.76 [-6.12, -3.41]