Early Feeds in Gastroschisis

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Davis
Study ID
NCT06878950
Status
Recruiting

Conditions

  • Gastroschisis

Eligibility Criteria

Sex
ALL
Age
0 Days - 1 Year
Healthy Volunteers
Not accepted

Interventions

  • Early Feeding Protocol — PROCEDURE
    The intervention includes removal of Replogle within 24 hours of abdominal closure and the initiation of introductory feeds within 48 hours of abdominal closure.

Study Details

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.

Key Dates

Start date
Feb 24, 2025
Status verified
Mar 2026
Primary completion
Feb 1, 2028
Completion
Feb 1, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

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

Locations (2)

FacilityCityStateZIPSite coordinators
University of California Los AngelesLos AngelesCalifornia90095
Kara Calkins, MD
Dan Deugarte, MD
UC Davis Children's HospitalSacramentoCalifornia95817
Nicole Cacho, DO
916-282-2507
Geoanna Bautista, MD

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