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Can early milk feeds help babies born with intestines outside the body?

NCT ID NCT06878950

Disease control Sponsor: University of California, Davis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether it is possible to start feeding breast milk early to newborns with gastroschisis, a condition where the intestines are outside the belly at birth. The goal is to see if parents agree to join the study and if doctors can follow the early feeding plan. Twenty infants will take part at UC Davis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Early Feeding Protocol
What this could lead to
If successful, this could show that early feeding is safe and practical for infants with gastroschisis, potentially improving their recovery and reducing hospital stays.
What could go wrong
This is a very small, early feasibility study with only 20 participants. It is not designed to prove that early feeding improves health outcomes, and results may not apply to all infants with gastroschisis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 days to 1 year

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

gastroschisis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastroschisis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UC Davis Children's Hospital

    RECRUITING

    Sacramento, California, 95817, United States

  • University of California Los Angeles

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

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