Background
Neonatal research evaluates many different outcomes using multiple measures. This can
prevent synthesis of trial results in meta-analyses and selected outcomes may not be
relevant to former patients, parents and health professionals.
Objective
To define a core outcome set (COS) for research involving infants receiving neonatal care in
a high income setting.
Design
Outcomes reported in neonatal trials and qualitative studies were systematically reviewed.
Stakeholders were recruited for a three-round international Delphi survey. A consensus
meeting was held to confirm the final COS, based upon the survey results.
Participants
Four hundred and fourteen former patients, parents, healthcare professionals and
researchers took part in the eDelphi survey; 173 completed all 3 rounds. Sixteen
stakeholders participated in the consensus meeting.
Results
The literature reviews identified 104 outcomes; these were included in round one.
Participants proposed ten additional outcomes; 114 outcomes were scored in round two and
three. Round one scores showed different stakeholder groups prioritised contrasting
outcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotising
enterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability,
quality of life, adverse events, visual impairment/blindness, hearing impairment /deafness,
retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia.
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Conclusions and relevance
A COS for clinical trials and other research studies involving infants receiving neonatal care
in a high-income setting has been identified. This COS for neonatology will help standardise
outcome selection in clinical trials and ensure these are relevant to those most affected by
neonatal care.