Core Outcome Set for Necrotizing Enterocolitis Treatment Trials

• DOI: 10.1542/peds.2023-065619
• Publication Date: 2024-05-10T08:06:27Z
• Authors: Daphne H. Klerk; Otis C. van Varss...; Martin Offringa; Neena Modi; Martin Lacher; Augusto Zani; Mikko P. Pakarinen; Antti Koivusalo; Ingo Jester; Marie Spruce; Joep P.M. Derikx; Roel Bakx; Amine Ksia; Elisabeth M.W. Kooi; Jan B.F. Hulscher
• Keywords: Delphi Method; Necrotizing Enterocolitis

BACKGROUND AND OBJECTIVES Variability in outcome reporting necrotizing enterocolitis (NEC) treatment trials hinders conducting meta-analyses and implementing novel treatments. We aimed to develop a core set (COS) for NEC including measures most relevant patients physicians, from diagnosis adulthood. METHODS Clinicians and/or researchers low–middle- high-income countries were approached based on their scientific contributions literature, parents through local organizations. presented participants with 45 outcomes used research, identified systematic review. To achieve consensus, rated scale of 1 9 3 online Delphi rounds, discussed at final consensus meeting. RESULTS Seventy-one 25 completed all 15 family representatives. Thirteen reached one the stakeholder groups included meeting, 6 both groups. Twenty-seven high- low–middle-income attended representatives patients. After discussion vote, 5 be included: mortality, NEC-related short bowel syndrome, quality life, neurodevelopmental impairment. CONCLUSIONS This COS includes predominantly long-term agreed upon by clinicians, patients, Use this international will help standardize selection clinical trials, ensure these are those affected care, and, ultimately, improve care infants NEC.