RecruitingNot ApplicableNCT06878950

Early Feeds in Gastroschisis

The GAIN Study: The Gastroschisis And Early Infant Nutrition Study

Sponsor

University of California, Davis

Enrollment

20 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

Conditions

gastroschisis

Summary

This study aims to evaluate the feasibility of initiating early feeds in neonates with gastroschisis, a condition where infants are born with their intestines outside the body.

Eligibility

Min Age: 0 DaysMax Age: 1 Year

Inclusion Criteria6

Neonates with presumed simple gastroschisis
Born at ≥ 34 weeks' gestation
Hemodynamically stable
Consented within 48 hours after abdominal closure
Mothers who are ≥16 years old
Mothers who speak English or Spanish

Exclusion Criteria7

Neonates with evidence of complex gastroschisis at time of closure (any ischemic bowel, intestinal perforation, or obvious atresia with mesenteric defect)
Presence of any major congenital anomalies
Neonates who are receiving ionotropic medications
Neonates who are wards of the state
Neonates whose care is considered to be futile or those undergoing re-direction of care
Neonates participating in another interventional trial
Any patient deemed unfit for participation by study investigator(s)

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Interventions

PROCEDUREEarly Feeding Protocol

The intervention includes removal of Replogle within 24 hours of abdominal closure and the initiation of introductory feeds within 48 hours of abdominal closure.