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Early Feeds in Gastroschisis

This study is looking at whether it's possible to start feeding babies with gastroschisis (a condition where intestines are outside the body at birth) sooner than usual. The study will test an "Early Feeding Protocol." This involves removing a tube called a Replogle within 24 hours of surgery and starting introductory feeds within 48 hours of surgery. You might be able to join if your baby has simple gastroschisis, was born at 34 weeks or more, is stable, and you are at least 16 years old and speak English or Spanish. The main goal is to see if it's practical to enroll babies in a study like this. The study plans to include 20 babies, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured from the prenatal period within the first 24 hours of abdominal closure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06878950

Early Feeds in Gastroschisis

Recruiting
NAAges 0–1InterventionalTreatment
University of California, Davis
~20 participants
Updated 2026-03-17 on ClinicalTrials.gov
What's tested:Early Feeding Protocol

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of Enrollment in Early Feeding Study Cohort
Measured over From prenatal period within the first 24 hours of abdominal closure

Conditions

Gastroschisis

Explore related trials

Gastroschisis

Where it's being run

2 sites across 1 states
California2

Study leadership

  • Nicole Cacho, DO · PRINCIPAL_INVESTIGATOR · University of California, Davis
  • Geoanna Bautista, MD · PRINCIPAL_INVESTIGATOR · University of California, Davis

Who to contact

Nicole Cacho, DO
[email protected]
(916) 282-2507
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Feasibility of Enrollment in Early Feeding Study CohortFrom prenatal period within the first 24 hours of abdominal closure

    Proportion of eligible neonates with gastroschisis whose parents/guardians consent to enrollment in the study.