The GAIN Study: The Gastroschisis And Early Infant Nutrition Study
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 1
Healthy Volunteers: f
View:
• 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
Locations
United States
California
University of California Los Angeles
NOT_YET_RECRUITING
Los Angeles
UC Davis Children's Hospital
RECRUITING
Sacramento
Contact Information
Primary
Nicole Cacho, DO
ntcacho@ucdavis.edu
(916) 282-2507
Backup
Geoanna Bautista, MD
gmbautista@ucdavis.edu
(916) 282-2507
Time Frame
Start Date: 2025-02-24
Estimated Completion Date: 2029-02-01
Participants
Target number of participants: 20
Treatments
Experimental: Early Feeding Protocol Group
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Center for Advancing Translational Sciences (NCATS), University of California Fetal Consortium, University of California, Los Angeles, The Gerber Foundation
Leads: University of California, Davis