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GAIN: a multicenter pilot protocol for early initiation of enteral feeds in neonates with simple gastroschisis
Nicole T Cacho1, Anjali J Cera2, Daniel J Tancredi1
1Department of Pediatrics, University of California Davis, Sacramento, CA, 95817, USA.
Insights
This study tests an early feeding protocol for infants with gastroschisis, a condition causing gut dysmotility. Early feeding may improve outcomes and reduce hospital stays for these neonates.
Area of Science:
- Neonatal surgery
- Pediatric gastroenterology
- Clinical trial methodology
Background:
- Gastroschisis is a congenital defect causing severe gut dysmotility in neonates.
- Current feeding practices involve prolonged bowel rest, leading to extended hospital stays and complications.
- Emerging evidence suggests early feeding protocols may improve outcomes for neonates with gastroschisis.
Purpose of the Study:
- To assess the feasibility of an early feeding approach in neonates with simple gastroschisis.
- To evaluate the safety and efficacy of initiating human milk feeds within 48 hours of abdominal closure.
- To inform future clinical trials on optimizing nutrition and outcomes for gastroschisis patients.
Main Methods:
- A two-site, single-arm feasibility trial enrolling neonates with simple gastroschisis.
- Intervention includes early removal of nasogastric tubes and initiation of small-volume human milk feeds.
- Feasibility assessed by enrollment rates, protocol adherence, and withdrawal rates; exploratory outcomes include hospitalization length and time to full feeds.
Main Results:
- Feasibility outcomes (enrollment, adherence, withdrawal) are key metrics.
- Exploratory outcomes will assess clinical benefits like reduced hospitalization and parenteral nutrition duration.
- Safety monitoring will track feeding-related complications and infections.
Conclusions:
- This feasibility trial is a crucial step towards a standardized feeding approach for gastroschisis.
- Findings may challenge the necessity of prolonged bowel rest and inform future clinical practice.
- Standardizing early feeding can potentially improve gut motility and overall health in affected neonates.
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.
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