Neonatal sepsis: a systematic review of core outcomes from randomised clinical trials

Cían J. Henry, Gergana Semova, Ellen Barnes, Isabel Cotter, Tara Devers, Aisyah Rafaee, Andreea Slavescu, Niamh O. Cathain, Danielle McCollum, Edna Roche, David Mockler, John Allen, Judith Meehan, Claus Klingenberg, Jos M. Latour, Agnes van den Hoogen, Tobias Strunk, Eric Giannoni, Luregn J. Schlapbach, Marina DegtyarevaFrans B. Plötz, Willem P. de Boode, Lars Naver, James L. Wynn, Helmut Küster, Jan Janota, Fleur M. Keij, Irwin K.M. Reiss, Joseph M. Bliss, Richard Polin, Joyce M. Koenig, Mark A. Turner, Christopher Gale, Eleanor J. Molloy*

*Corresponding author for this work

Research output: Contribution to journalReview articleAcademicpeer-review

10 Citations (Scopus)
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Abstract

Background: The lack of a consensus definition of neonatal sepsis and a core outcome set (COS) proves a substantial impediment to research that influences policy and practice relevant to key stakeholders, patients and parents.  

Methods: A systematic review of the literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. In the included studies, the described outcomes were extracted in accordance with the provisions of the Core Outcome Measures in Effectiveness Trials (COMET) handbook and registered.  

Results: Among 884 abstracts identified, 90 randomised controlled trials (RCTs) were included in this review. Only 30 manuscripts explicitly stated the primary and/or secondary outcomes. A total of 88 distinct outcomes were recorded across all 90 studies included. These were then assigned to seven different domains in line with the taxonomy for classification proposed by the COMET initiative. The most frequently reported outcome was survival with 74% (n = 67) of the studies reporting an outcome within this domain.  

Conclusions: This systematic review constitutes one of the initial phases in the protocol for developing a COS in neonatal sepsis. The paucity of standardised outcome reporting in neonatal sepsis hinders comparison and synthesis of data. The final phase will involve a Delphi Survey to generate a COS in neonatal sepsis by consensus recommendation.  

Impact: * This systematic review identified a wide variation of outcomes reported among published RCTs on the management of neonatal sepsis. * The paucity of standardised outcome reporting hinders comparison and synthesis of data and future meta-analyses with conclusive recommendations on the management of neonatal sepsis are unlikely. * The final phase will involve a Delphi Survey to determine a COS by consensus recommendation with input from all relevant stakeholders.

Original languageEnglish
Pages (from-to)735-742
Number of pages8
JournalPediatric Research
Volume91
Issue number4
DOIs
Publication statusPublished - Mar 2022

Bibliographical note

On behalf of the Infection, Inflammation, Immunology and Immunisation (I4) section of the European Society for Paediatric Research (ESPR)

Funding Information:
The Neonatal sepsis series was funded by ESPR. This work was supported by the Health Research Board. This publication has received funding from the European Society for Paediatric Research (ESPR) and was realised by its Infection, Inflammation, Immunology and Immunization section. The funder had no role in the study design, data collection and analysis, preparation of the manuscript or decision to publish.

Publisher Copyright:
© 2022, The Author(s).

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