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Could starting feeds sooner shield preterm babies from infection?

NCT ID NCT06893939

Disease control Sponsor: University of Washington 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Last updated Aug 18, 2026 · Updated 2 times

Summary

This trial compares two ways of feeding very preterm infants (born before 32 weeks and under 1500 grams). One group receives a short period of small 'trophic' feeds for one day before advancing to full feeds, while the other receives trophic feeds for three days. The goal is to see if the shorter period reduces the risk of late-onset sepsis, a serious infection, without increasing other complications. The study will also look at hospital stay length, growth, and developmental outcomes at age two.

What this could mean

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

Active substance
Limited trophic feeding (1 day) versus extended trophic feeding (3 days) before advancing enteral feeds
What this could lead to
If limited trophic feeding works, it could reduce dangerous infections in preterm babies and shorten hospital stays.
What could go wrong
This is a mid-stage trial, so results may not be definitive. There is a risk that faster feeding could increase other complications like necrotizing enterocolitis.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 350 people

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

Started

Jul 2025

Expected to finish

Feb 2031

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 to 2 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * \<1500 gram birthweight * 25w0d-31w6d at birth * Consent to feed donor milk when parent's own milk is not available or of insufficient quantity Exclusion Criteria: * \<5th percentile for weight at birth (Fenton growth curve) * Parent or legal guardian unable to provide consent within 36 hours after birth * Congenital anomaly affecting decisions on enteral feedings (e.g. gastroschisis, omphalocele, congenital diaphragmatic hernia, congenital heart disease, etc.) * Known genetic condition affecting growth, feeding, or mortality * Vasopressor use within first 24 hours after birth (not including hydrocortisone) * Considered terminally ill

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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis neurodevelopmental disorder Premature Birth Sepsis

As listed by the trial registrant

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

Length of stay Mortality Neurodevelopmental delay Sepsis

How to take part

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

  1. The places running it

    6 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

  • Baylor College of Medicine

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • St. Joseph's Medical Center

    RECRUITING

    Tacoma, Washington, 98405, United States

  • University of Alabama at Birmingham

    NOT_YET_RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Oklahoma

    NOT_YET_RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of South Florida

    NOT_YET_RECRUITING

    Tampa, Florida, 33606, United States

  • University of Washington

    NOT_YET_RECRUITING

    Seattle, Washington, 98195, United States

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