Optimal outcome measures for a trial of not routinely measuring gastric residual volume in neonatal care: a mixed methods consensus process.

Background: Routine measurement of gastric residual volume to guide feeding is widespread in neonatal units but not supported by high-quality evidence. Outcome selection is critical to trial design.
Objective: To determine optimal outcome measures for a trial of not routinely measuring gastric residual volume in neonatal care.
Design: A focused literature review, parent interviews, modified two-round Delphi survey and stakeholder consensus meeting.
Participants: Sixty-one neonatal healthcare professionals participated in an eDelphi survey; 17 parents were interviewed. 19 parents and neonatal healthcare professionals took part in the consensus meeting.
Results: Literature review generated 14 outcomes, and parent interviews contributed eight additional outcomes; these 22 outcomes were then ranked by 74 healthcare professionals in the first Delphi round where four further outcomes were proposed; 26 outcomes were ranked in the second round by 61 healthcare professionals. Five outcomes were categorised as 'consensus in', and no outcomes were voted 'consensus out'. 'No consensus' outcomes were discussed and voted on in a face-to-face meeting by 19 participants, where four were voted 'consensus in'. The final nine consensus outcomes were: mortality, necrotising enterocolitis, time to full enteral feeds, duration of parenteral nutrition, time feeds stopped per 24 hours, healthcare-associated infection; catheter-associated bloodstream infection, change in weight between birth and neonatal discharge and pneumonia due to milk aspiration.
Conclusions and Relevance: We have identified outcomes for a trial of no routine measurement of gastric residual volume to guide feeding in neonatal care. This outcome set will ensure outcomes are important to healthcare professionals and parents.
Competing Interests: Competing interests: CG reports grants from Medical Research Council and the NIHR during the conduct of the study; grants from NIHR, Mason Medical Research Foundation, Rosetrees Foundation and from Canadian Institute for Health Research outside the submitted work. He reports grants and personal fees from Chiesi Pharmaceuticals outside of the submitted work; the grant is for a research study, and the personal fee was to support attendance at an educational meeting. CG is vice-chair of the NIHR Research for Patient Benefit London Regional Assessment Panel and has sat on the panel since 2016. JD reports grants from NIHR, during the conduct of the study for the study; grants from NIHR, and grants from Nutrinia, outside the submitted work. The grant from Nutrinia in 2018 was for part of his salary to work as an expert advisor on a trial. JD was a member of the NIHR HTA General Board (from 2017 to 2018) and the NIHR HTA Maternity, Newborn and Child Health Panel (from 2013 to 2018). FV reports personal fees from BAXTER, personal fees from NUTRICIA, outside the submitted work. LT is an NIHR HTA panel member.
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