Differences in attitudes to feeding post repair of Gastroschisis and development of a standardized feeding protocol.
Donna Hobson, Kaye Spence, Amit Trivedi...
https://pubmed.ncbi.nlm.nih.gov/31801489Actively Recruiting
Phase Not Applicable
Age: 0Days - 1Year
All Genders
ID06878950
The GAIN Study: The Gastroschisis And Early Infant Nutrition Study
Led by University of California, Davis · Updated on 2026-03-17
20
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
T
The Gerber Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility of starting early feeding in newborns with gastroschisis, a condition where the intestines develop outside the body. The study focuses on infants born at 34 weeks or later who have simple gastroschisis and are stable after surgery. This trial aims to understand if initiating feeds early is practical and how well infants tolerate and adhere to the feeding protocol. The study involves an early feeding protocol where human milk feeding begins within 48 hours of surgical repair and removal of the Replogle tube within 24 hours after abdominal closure. Feeds are gradually increased based on the infant's tolerance and clinical assessments, with attention to supporting oral motor skill development. This intervention takes place from the prenatal period through hospital discharge, averaging about 90 days. Participants will be monitored closely from enrollment soon after birth until hospital discharge. Researchers will assess feasibility of enrollment, adherence to the feeding protocol, fidelity to the treatment plan, and reasons for any withdrawal from the protocol. The study also observes clinical stability throughout the feeding advancement period. Overall, the trial seeks to gather detailed information on the early feeding process and outcomes in this newborn population.
CONDITIONS
Brief Title
Early Feeds in Gastroschisis
Who Can Participate
Age: 0Days - 1Year
All Genders
Eligibility Criteria
You may qualify if you...
- Neonates with presumed simple gastroschisis
- Born at 64 34 weeks' gestation
- Hemodynamically stable
- Consented within 48 hours after abdominal closure
- Mothers who are 6516 years old
- Mothers who speak English or Spanish
You will not qualify if you...
- Neonates with evidence of complex gastroschisis at time of closure (ischemic bowel, intestinal perforation, or atresia with mesenteric defect)
- Presence of any major congenital anomalies
- Neonates receiving ionotropic medications
- Neonates who are wards of the state
- Neonates considered to have futile care or undergoing care re-direction
- Neonates participating in another interventional trial
- Any patient deemed unfit for participation by study investigator(s)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 90 days until hospital discharge
Participants undergo surgical repair of gastroschisis followed by an early feeding protocol starting within 48 hours of abdominal closure. Feeds are advanced based on tolerance and clinical assessment to support oral motor skill development.
Visits as part of hospital care until discharge
Trial Site Locations
Total: 2 locations
1
University of California Los Angeles
Los Angeles, California, United States, 90095
Not Yet Recruiting
2
UC Davis Children's Hospital
Sacramento, California, United States, 95817
Actively Recruiting
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Research Team
N
Nicole Cacho, DO
G
Geoanna Bautista, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Adherence to and outcomes of a University-Consortium gastroschisis pathway.
Daniel A DeUgarte, Kara L Calkins, Yigit Guner...
https://pubmed.ncbi.nlm.nih.gov/31704046Evaluation of gastroschisis feeding protocol: A retrospective cohort study.
Jeewan Jyoti, Kristen James-Nunez, Kaye Spence...
https://pubmed.ncbi.nlm.nih.gov/39206671