Pilot and feasibility studies · 2026
GAIN: a multicenter pilot protocol for early initiation of enteral feeds in neonates with simple gastroschisis.
СтатьяНазвание и аннотация: Перевод в очереди
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Cacho Nicole T, Cera Anjali J, Tancredi Daniel J, Wieck Minna M, Anderson Jamie E, Leegwater Alexandra J, Uy Cherry C, Guner Yigit S, DeUgarte Daniel A, Rosenthal Jennifer L, Calkins Kara L, Bautista Geoanna M, University of California Fetal Consortium (UCfC)
Аннотация
BACKGROUND: Gastroschisis is a congenital abdominal wall defect characterized by severe gut dysmotility. These neonates often face lengthy hospital stays, prolonged parenteral nutrition dependence, and complications such as growth faltering, sepsis, and intestinal failure. Feeding practices for neonates with gastroschisis vary and emphasize extended bowel rest and delayed feeding initiation. Usual practices in determining timing to start feeds include awaiting return of bowel function which typically consists of low Replogle output volume, color changing from bilious to clear and/or passing stool. However, emerging studies suggest that early initiation of feeds through standardized protocols may improve outcomes. The Gastroschisis And Early Infant Nutrition (GAIN) Study aims to test the feasibility of an early feeding approach in neonates with simple gastroschisis.
METHODS: This two-site single-arm feasibility trial aims to enroll neonates with presumed simple gastroschisis over 30 months. The intervention has two main components: Replogle suction tube removal within 24 h of abdominal closure and starting small-volume human milk feeds within 48 h of abdominal closure. Feeding volume will be advanced as tolerated, following the University of California Fetal Consortium pathway, which is standard care. Feasibility outcomes include enrollment rate, protocol adherence, fidelity, and withdrawal rate. Exploratory outcomes include hospitalization length, time to full feeds, duration of parenteral nutrition, use of human milk, breastfeeding rates, and anthropometric measurements. Safety measures involve monitoring for feeding-related complications, infections, and unexpected surgical interventions.
DISCUSSION: This feasibility trial of early feeding initiation in neonates with gastroschisis is a critical step towards addressing the need for a standardized feeding approach. Findings will inform future clinical trials and challenge the need for prolonged bowel rest. Standardizing early feeding practices could reduce practice variation, improve gut motility, and the overall health of neonates with gastroschisis.
SYSTEMATIC REVIEW REGISTRATION: NCT06878950.
METHODS: This two-site single-arm feasibility trial aims to enroll neonates with presumed simple gastroschisis over 30 months. The intervention has two main components: Replogle suction tube removal within 24 h of abdominal closure and starting small-volume human milk feeds within 48 h of abdominal closure. Feeding volume will be advanced as tolerated, following the University of California Fetal Consortium pathway, which is standard care. Feasibility outcomes include enrollment rate, protocol adherence, fidelity, and withdrawal rate. Exploratory outcomes include hospitalization length, time to full feeds, duration of parenteral nutrition, use of human milk, breastfeeding rates, and anthropometric measurements. Safety measures involve monitoring for feeding-related complications, infections, and unexpected surgical interventions.
DISCUSSION: This feasibility trial of early feeding initiation in neonates with gastroschisis is a critical step towards addressing the need for a standardized feeding approach. Findings will inform future clinical trials and challenge the need for prolonged bowel rest. Standardizing early feeding practices could reduce practice variation, improve gut motility, and the overall health of neonates with gastroschisis.
SYSTEMATIC REVIEW REGISTRATION: NCT06878950.