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

Area of Science:

• Neonatal intensive care
• Clinical trial methodology
• Evidence-based practice

Background:

• Routine measurement of gastric residual volume in neonatal units lacks strong evidence.
• Optimal outcome selection is crucial for designing effective clinical trials in neonatal care.

Purpose of the Study:

• To establish the most relevant outcome measures for a clinical trial evaluating the cessation of routine gastric residual volume measurement in neonates.
• To align trial outcomes with the priorities of healthcare professionals and parents.

Main Methods:

• A comprehensive approach combining literature review, parent interviews, a modified Delphi survey with 61 neonatal healthcare professionals, and a stakeholder consensus meeting.
• Inclusion of 17 parents in interviews and 19 parents and professionals in the consensus meeting to gather diverse perspectives.

Main Results:

• Initial literature review and parent interviews generated 22 potential outcomes.
• A two-round Delphi survey involving 74 and 61 healthcare professionals respectively, followed by a consensus meeting with 19 participants, refined the outcome list.
• Nine consensus outcomes were finalized: 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, and pneumonia due to milk aspiration.

Conclusions:

• A definitive set of nine outcomes has been identified for trials investigating the practice of not routinely measuring gastric residual volume in neonatal feeding.
• This consensus-driven outcome set ensures that the trial's endpoints are significant and relevant to both clinical practice and patient family experiences.