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Breast milk may speed up feeding in newborns with gut defects

NCT ID NCT06072976

Disease control Sponsor: Seattle Children's Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether feeding babies with congenital gastrointestinal issues (like gastroschisis or Hirschsprung disease) only human milk helps them reach full feeds faster than standard care, which may include formula. Researchers will also look at gut bacteria and infection rates. The study involves 116 newborns at Seattle Children's Hospital.

What this could mean

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

Active substance
exclusive human milk diet (mother's own milk or donor milk)
What this could lead to
If it works, this could show that an exclusive human milk diet helps babies with intestinal differences reach full feeds faster and reduces infections.
What could go wrong
This is a small, early-stage study (116 infants) comparing two feeding approaches, not a new drug. Results may not apply to all babies, and donor milk is only used briefly.

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 116 people

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

Started

Jun 2023

Expected to finish

Jun 2027

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 55 years

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 gastroschisis, giant omphalocele, intestinal atresia, mid-gut volvulus, hirschsprungs disease. Exclusion Criteria: 1. Infant has already been on feeds 2. Infants \<34 weeks gestation 3. Parents with contraindications to providing milk (i.e. drug use-cocaine, fentanyl, meth BUT oxy/suboxone/marijuana OK) 4. Complicated gastroschisis 5. Short gut syndrome 6. Additional congenital anomalies that affect ability to tolerate milk (i.e. cyanotic congenital heart disease BUT kidney disease ok)

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Conditions

The condition(s) this trial relates to.

gastroschisis giant omphalocele Hernia, Umbilical Hirschsprung disease intestinal atresia intestinal obstruction omphalocele volvulus of midgut

As listed by the trial registrant

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

Gastrointestinal complication Gastroschisis Hirschsprung disease Intestinal obstruction Midgut volvulus Omphalocele

How to take part

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

  1. The places running it

    1 site. 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

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

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