Protocol for the development of a core outcome set for neonatal sepsis (NESCOS)

Neonatal sepsis is a serious public health problem; however, there is substantial heterogeneity in the outcomes measured and reported in research evaluating the effectiveness of the treatments. Therefore, we aim to develop a Core Outcome Set (COS) for studies evaluating the effectiveness of treatments for neonatal sepsis. Since a systematic review of key outcomes from randomised trials of therapeutic interventions in neonatal sepsis was published recently, we will complement this with a qualitative systematic review of the key outcomes of neonatal sepsis identified by parents, other family members, parent representatives, healthcare providers, policymakers, and researchers. We will interpret the outcomes of both studies using a previously established framework. Stakeholders across three different groups i.e., (1) researchers, (2) healthcare providers, and (3) patients’ parents/family members and parent representatives will rate the importance of the outcomes in an online Real-Time Delphi Survey. Afterwards, consensus meetings will be held to agree on the final COS through online discussions with key stakeholders. This COS is expected to minimize outcome heterogeneity in measurements and publications, improve comparability and synthesis, and decrease research waste.


We aim to develop a Core Outcome Set (COS) for studies evaluating the effectiveness of treatments for neonatal sepsis.


Petek Eylul Taneri, Jamie J. Kirkham, Eleanor J. Molloy, Linda Biesty, Richard A. Polin, James L. Wynn, Barbara J. Stoll, Niranjan Kissoon, Kondwani Kawaza, Mandy Daly, Aoife Branagan, Lívia Nagy Bonnard, Eric Giannoni, Tobias Strunk, Magdalena Ohaja, Kenneth Mugabe, Denise Suguitani, Fiona Quirke, Declan Devane


Journal: PLoS ONE
Volume: 18
Issue: 12
Pages: -
Year: 2023
DOI: 10.1371/journal.pone.0295325

Further Study Information

Current Stage: Completed
Funding source(s): This research was funded by the Health Research Board (HRB, Ireland) through funding to the HRB Irish Network for Children’s Clinical Trials (In4Kids) [Grant number: CTN-2021-007]

Health Area

Disease Category: Neonatal care

Disease Name: Sepsis

Target Population

Age Range: Unknown

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Families
- Patient/ support group representatives
- Researchers

Study Type

- COS (Other)


- Consensus meeting
- Delphi process
- Systematic review

The study will be conducted in four stages: (1) qualitive systematic review, (2) Delphi survey (3) consensus meetings and (4) dissemination and implementation strategy.