Status:
RECRUITING
Early Feeds in Gastroschisis
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
The Gerber Foundation
University of California, Los Angeles
Conditions:
Gastroschisis
Eligibility:
All Genders
Up to 1 years
Phase:
NA
Brief 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 Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06878950
Start Date
February 24 2025
End Date
February 1 2029
Last Update
March 17 2025
Active Locations (2)
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1
University of California Los Angeles
Los Angeles, California, United States, 90095
2
UC Davis Children's Hospital
Sacramento, California, United States, 95817