Early Feeds in Gastroschisis (GAIN)

University of California (UC) Davis

Status: Enrolling

Conditions: Gastroschisis

Treatments: Procedure: Early Feeding Protocol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06878950

2216195

UL1TR001860 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Early Feeding Protocol Group

Experimental group

Description:

This arm involves neonates with presumed simple gastroschisis who will be subjected to an early feeding protocol. The protocol specifies initiating human milk feeds within 48 hours of surgical repair of gastroschisis. Feeds are advanced based on tolerance and clinical assessment, with a focus on promoting oral motor skill development.

Treatment:

Procedure: Early Feeding Protocol