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Early Feeds in Gastroschisis | Clinical Trials | Clareo Health

RECRUITINGNA

Early Feeds in Gastroschisis

The GAIN Study: The Gastroschisis And Early Infant Nutrition Study

NCT06878950•University of California, Davis

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

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

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)

Locations (2)

University of California Los Angeles

Los Angeles, California, United States

UC Davis Children's Hospital

Sacramento, California, United States

Key Dates

Start Date

February 24, 2025

Primary Completion Date

February 1, 2028

Completion Date

February 1, 2029

Last Updated

March 17, 2026

Enrollment

ESTIMATED participants

Conditions

Gastroschisis

Interventions

Early Feeding Protocol

PROCEDURE

Contacts

Nicole Cacho, DO

CONTACT

(916) 282-2507 ntcacho@ucdavis.edu

Geoanna Bautista, MD

CONTACT

(916) 282-2507 gmbautista@ucdavis.edu

Gastroschisis Outcomes of Delivery (GOOD) Study

NCT02774746

Gastroschisis

View study

RECRUITING

An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels

NCT06731855

GastroschisisCongenital Diaphragmatic Hernia+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Early Feeds in Gastroschisis

Inclusion Criteria

Exclusion Criteria

Gastroschisis Outcomes of Delivery (GOOD) Study

An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels

Surgical Management Of Gastroschisis

The Use of Gastrografin to Help Alleviate Bowel Obstruction in Gastroschisis Patients.

Prospective Study of Antenatal Diagnostic Criteria for Digestive Complications of Gastroschisis

Compassionate Use of Omegaven in Children