COHESION: Core Outcomes in Neonatal Encephalopathy

BACKGROUND: Heterogeneity in outcomes reported in trials of interventions for the treatment of neonatal encephalopathy (NE) makes evaluating the effectiveness of treatments difficult. Developing a core outcome set for NE treatment would enable researchers to measure and report the same outcomes in future trials. This would minimise waste, ensure relevant outcomes are measured and enable evidence synthesis. Therefore, we aimed to develop a core outcome set for treating NE.
METHODS: Outcomes identified from a systematic review of the literature and interviews with parents were prioritised by stakeholders (n = 99 parents/caregivers, n = 101 healthcare providers, and n = 22 researchers/ academics) in online Delphi surveys.
Agreement on the outcomes was achieved at online consensus meetings attended by n = 10 parents, n = 18 healthcare providers, and n = 13 researchers/ academics.
RESULTS: Seven outcomes were included in the final core outcome set: survival; brain injury on imaging; neurological status at discharge; cerebral palsy; general cognitive ability; quality of life of the child, and adverse events related to treatment.
CONCLUSION: We developed a core outcome set for the treatment of NE. This will allow future trials to measure and report the same outcomes and ensure results can be compared. Future work should identify how best to measure the COS.


Ms Fiona Quirke1, Dr Patricia Healy2,3,4, Elaine Ní Bhraoináin5, Dr Linda Biesty2,4, Mr Tim Hurley1, Prof Karen Walker6 Dr Shireen Meher7, Prof David Haas8, Prof Frank Bloomfield9, Prof Eleanor Molloy1,10, Prof Declan Devane1,2,3,4,11.

1HRB Neonatal Encephalopathy PhD Training Network (NEPTuNE), NUI Galway
2Health Research Board – Trials Methodology Research Network, Ireland
3Evidence Synthesis Ireland, NUI Galway
4School of Nursing and Midwifery, NUI Galway, Galway, Ireland
5PPI partner and board member of the Irish Neonatal Health Alliance (INHA)
6Grace Centre for Newborn Intensive Care, Australian College of Neonatal Nurses, Council of International Neonatal Nurses
7Department of Women's and Children's Health, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom
8Indiana University-Purdue University Indianapolis, USA
9Liggins Institute, University of Auckland, Auckland, New Zealand
10Trinity College, the University of Dublin, Trinity Translational Medicine Institute, Dublin
11Cochrane Ireland, NUI Galway


Journal: Pediatric Research
Pages: -
Year: 2023
DOI: 10.1038/s41390-023-02938-y

Further Study Information

Current Stage: Completed
Date: September 2018 - September 2022
Funding source(s): This research was funded by the Health Research Board (HRB), Neonatal Encephalopathy PhD Training Network (HRB-NEPTuNE) and supported by the HRB-Trials Methodology Research Network.

Health Area

Disease Category: Neonatal care

Disease Name: Neonatal Encephalopathy

Target Population

Age Range: 0 - 0

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Families
- Patient/ support group representatives
- Policy makers
- Researchers
- Service providers
- Service users

Study Type

- COS for clinical trials or clinical research
- COS for practice


- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Systematic review

We will develop the COS through five discrete, yet complimentary, phases (see Figure 1):
Phase 1: A systematic review of the literature to identify outcomes that have been reported in trials and systematic reviews of trials of interventions for the treatment of Neonatal Encephalopathy;
Phase 2: Interviews to obtain the views of women, their partners, other family members who may care for the infant and healthcare providers on critical outcomes they feel should be measured to determine the effect of treatment for Neonatal Encephalopathy;
Phase 3: Development of a preliminary COS (informed by Phases 1 & 2) through a three-round web-based Delphi survey with key stakeholders;
Phase 4: Consensus meeting to discuss and agree on the final Neonatal Encephalopathy COS;
Phase 5: Implementation of a dissemination and implementation strategy for the final COS.