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Updated: Oct 7, 2025
A Neonatal Imaging Model of Gram-Negative Bacterial Sepsis
Published on: August 12, 2020
Neonatal sepsis: a systematic review of core outcomes from randomised clinical trials
Cían J Henry1, Gergana Semova1, Ellen Barnes1
1Discipline of Paediatrics, Trinity College Dublin, The University of Dublin & Children's Hospital Ireland (CHI) at Tallaght, Dublin, Ireland.
Insights
Neonatal sepsis research lacks a standard definition and core outcome set, hindering progress. This review found varied outcomes in 90 trials, paving the way for a consensus-based core outcome set development.
Area of Science:
- Neonatal Medicine
- Clinical Trials Methodology
- Evidence Synthesis
Background:
- Lack of a consensus definition and core outcome set (COS) for neonatal sepsis impedes research, policy, and practice.
- Standardized outcomes are crucial for comparing and synthesizing data in neonatal sepsis studies.
Approach:
- Systematic literature review following PRISMA guidelines.
- Extracted outcomes from 90 randomized controlled trials (RCTs) according to COMET handbook.
- Classified 88 distinct outcomes into seven domains based on COMET taxonomy.
Key Points:
- Only 30 of 90 included RCTs explicitly stated primary/secondary outcomes.
- Survival was the most frequently reported outcome (74%).
- Significant variation in reported outcomes hinders data comparison and meta-analysis.
Conclusions:
- This systematic review is a foundational step towards developing a COS for neonatal sepsis.
- Standardized outcome reporting is essential for advancing neonatal sepsis research.
- A Delphi survey will be used to establish a consensus-based COS involving stakeholders.
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.
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