Early Feeding for Gastroschisis
(GAIN Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byNicole Cacho, DO

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Davis

No Placebo Group

Trial Summary

What is the purpose of this trial?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

This trial is for newborns with gastroschisis, where their intestines are outside the body at birth. The study will include those who meet specific health criteria set by the researchers.

Inclusion Criteria

Born at ≥ 34 weeks' gestation

My newborn has gastroschisis without complications.

My heart and blood circulation are stable.

+3 more

Exclusion Criteria

Presence of any major congenital anomalies

Neonates whose care is considered to be futile or those undergoing re-direction of care

Any patient deemed unfit for participation by study investigator(s)

+4 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

Prenatal period

Treatment

Neonates with gastroschisis undergo surgical repair and are initiated on early feeding protocol within 48 hours post-surgery

From abdominal closure through discharge, average of 90 days

Follow-up

Participants are monitored for safety, growth parameters, and feeding progression after treatment

Assessed up to 1 year

Participant Groups

The study is testing an Early Feeding Protocol to see if it's possible and safe to start feeding these infants sooner than currently recommended.

1Treatment groups

Experimental Treatment

Group I: Early Feeding Protocol GroupExperimental Treatment1 Intervention

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.