Evaluating early feeding in newborns with gastroschisis
The GAIN Study: The Gastroschisis And Early Infant Nutrition Study
This study is testing if starting to feed newborns with gastroschisis soon after their surgery is safe and helpful for their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 0 Days to 1 Year |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT06878950 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of starting early feeding protocols in neonates diagnosed with gastroschisis, a condition where the intestines are located outside the body at birth. The intervention involves initiating feeds shortly after surgical closure of the abdominal wall. Eligible participants include hemodynamically stable neonates born at or after 34 weeks of gestation, with parental consent obtained within 48 hours post-surgery. The study aims to determine if early feeding can be safely implemented in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are neonates with simple gastroschisis who are hemodynamically stable and born at 34 weeks or later.
Not a fit: Patients with complex gastroschisis or major congenital anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved nutritional outcomes and faster recovery for infants with gastroschisis.
How similar studies have performed: While the specific approach of early feeding in gastroschisis is being evaluated, similar studies in neonatal care have shown promising results in improving outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Los Angeles, California and 1 other locations
- University of California Los Angeles — Los Angeles, California, United States (Not_yet_recruiting)
- UC Davis Children's Hospital — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Nicole Cacho, DO — University of California, Davis
- Study coordinator: Nicole Cacho, DO
- Email: ntcacho@ucdavis.edu
- Phone: (916) 282-2507
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.