Randomized controlled trials of antibiotics for neonatal infections: a systematic review

Authors

  • Florentia Kaguelidou,

    Corresponding author
    1. Sorbonne Paris Cité, Univ Paris Diderot, Paris, France
    • Department of Paediatric Pharmacology and Pharmacogenetics, INSERM CIC9202, APHP, Hopital Robert Debré, Paris
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  • Mark A. Turner,

    1. Department of Women's and Children's Health, University of Liverpool, Neonatal Unit, Liverpool Women's Hospital, Liverpool
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  • Imti Choonara,

    1. Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK
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  • John van Anker,

    1. Division of Paediatric Clinical Pharmacology, Children's National Medical Center, Washington, DC
    2. Departments of Paediatrics, Pharmacology and Physiology, George Washington University School of Medicine and Health Sciences, Washington, DC, USA
    3. Intensive Care, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, the Netherlands
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  • Paolo Manzoni,

    1. Neonatology and NICU, S. Anna Hospital, Torino, Italy
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  • Corinne Alberti,

    1. Sorbonne Paris Cité, Univ Paris Diderot, Paris, France
    2. Department of Clinical Epidemiology, INSERM CIE5, APHP, Hopital Robert Debre, Paris, France
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  • Jean-Paul Langhendries,

    1. NICU, CHC-Site St Vincent, Rocourt-Liège, Belgium
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  • Evelyne Jacqz-Aigrain

    1. Department of Paediatric Pharmacology and Pharmacogenetics, INSERM CIC9202, APHP, Hopital Robert Debré, Paris
    2. Sorbonne Paris Cité, Univ Paris Diderot, Paris, France
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Errata

This article is corrected by:

  1. Errata: Corrigendum Volume 76, Issue 5, 840, Article first published online: 21 October 2013

Correspondence

Dr Florentia Kaguelidou, Department of Paediatric Pharmacology and Pharmacogenetics, CIC9202, Hopital Robert Debré, 48 boulevard Serurier, 75019, Paris, France.

Tel.: +33 1 4003 4142

Fax: +33 1 4003 2424

E-mail: florentia.kaguelidou@rdb.aphp.fr

Abstract

Aims

Antibiotics are a key resource for the management of infectious diseases in neonatology and their evaluation is particularly challenging. We reviewed medical literature to assess the characteristics and quality of randomized controlled trials on antibiotics in neonatal infections.

Methods

We performed a systematic search of PubMed, Embase and the Cochrane Library from January 1995 to March 2010. Bibliographies of relevant articles were also hand-searched. We included all randomized controlled trials that involved neonates and evaluated the use of an antibiotic agent in the context of a neonatal infectious disease. Methodological quality was evaluated using the Jadad scale and the Cochrane Risk of Bias Tool. Two reviewers independently assessed studies for inclusion and evaluated methodological quality.

Results

A total of 35 randomized controlled trials were evaluated. The majority were conducted in a single hospital institution, without funding. Median sample size was 63 (34–103) participants. The most frequently evaluated antibiotic was gentamicin. Respectively, 18 (51%) and 17 (49%) trials evaluated the therapeutic or prophylactic use of antibiotics in various neonatal infections. Overall, the methodological quality was poor and did not improve over the years. Risk of bias was high in 66% of the trials.

Conclusions

Design and reporting of randomized controlled trials of antibacterial agents in neonates should be improved. Nevertheless, the necessity of implementing such trials when antibacterial efficacy has already been established in other age groups may be questioned and different methods of evaluation should be further developed.

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