Recruiting

Early Feeds

Sponsor:

UCLA

Code:

NCT06878950

Conditions

Gastroschisis

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Early Feeding Protocol

Study Details

Brief 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.

Conditions

Gastroschisis

Study ID

NCT06878950

Start date

Feb 24, 2025

Status verified date

Mar, 2026

Completion date

Feb 1, 2029

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Early Feeding Protocol Group

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.

Interventions

Early Feeding Protocol

The intervention includes removal of Replogle within 24 hours of abdominal closure and the initiation of introductory feeds within 48 hours of abdominal closure.

Primary outcome measure

  • Feasibility of Enrollment in Early Feeding Study Cohort [ Time Frame: From prenatal period within the first 24 hours of abdominal closure ]

Central Contacts and Locations

Central contacts

Nicole Cacho, DO

(916) 282-2507ntcacho@ucdavis.edu

Geoanna Bautista, MD

(916) 282-2507gmbautista@ucdavis.edu

Locations

UC Davis Children's Hospital

Recruiting

Sacramento, California, United States, 95817

Contacts

Nicole Cacho, DO

916-282-2507

More Information

Sponsor

University of California, Davis

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Keywords

  • Gastroschisis
  • Early feeds in Gastroschisis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-03-17.