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Breast milk mouth care may boost gut health in rare birth defect

NCT ID NCT03393832

Knowledge-focused Sponsor: Baylor College of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether giving oral care with breast milk (or sterile water if breast milk is not available) can improve feeding tolerance and gut bacteria in newborns with gastroschisis, a rare abdominal wall defect. Researchers will follow 27 infants in the NICU to see if this simple practice helps them start and reach full feeds sooner and reduces hospital stay. The study is observational, meaning it observes outcomes without assigning treatments.

What this could mean

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

Active substance
breast milk (oral care)
What this could lead to
If it works, this could point toward a simple, low-cost way to improve feeding and reduce infections in infants with gastroschisis.
What could go wrong
This is a small observational study with only 27 infants, so results may not apply to all babies. It is not a treatment trial and cannot prove cause and effect.

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.

Participants

27 people

The number who actually took part.

Started

Oct 2017

Expected to finish

Dec 2026

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.

Who is studied

Infants with a diagnosis of gastroschisis are identified either prenatally through the Texas Children's Hospital Fetal Center or upon admission to the Texas Children's Hospital Neonatal Intensive Care Unit (NICU).

Ages

Up to 3 days

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: • Infants with a primary diagnosis of gastroschisis Exclusion Criteria: * Gestational age less than 30 weeks * Birth weight less than 1,000 g * Other major congenital anomalies or clinically significant heart disease * First dose of oral care greater than 72 hours after birth * Early transfer to another institution

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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

Contacts and locations

Locations

  • Texas Children's Hospital Fetal Center and Newborn Center

    Houston, Texas, 770230, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.