Early Feeding for Gastroschisis

(GAIN Trial)

Recruiting at 1 trial location

Overseen By Nicole Cacho, DO

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Ionotropic medications

Disqualifiers: Complex gastroschisis, Major anomalies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: From abdominal closure through discharge, average of 90 days

20 Participants Needed

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.

Research Team

Nicole Cacho, DO

Principal Investigator

University of California, Davis

Geoanna Bautista, MD

Principal Investigator

University of California, Davis

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.

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)

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

Treatment Details

Interventions

• Early Feeding Protocol

Trial Overview 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.

Participant Groups

Group I: Early Feeding Protocol Group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

The Gerber Foundation

Collaborator

Trials

45

Recruited

6,200+

University of California Fetal Consortium

Collaborator

Trials

1

Recruited

20+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+