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Could donor milk save tiny babies from deadly gut disease?

NCT ID NCT07045844

Disease control Sponsor: The Children's Hospital of Zhejiang University School 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 large trial studies over 2,300 very preterm infants (born before 29 weeks) to see whether supplementing mother's milk with pasteurized donor milk or preterm formula improves survival without severe necrotizing enterocolitis (NEC), a dangerous gut condition. It also tests whether routine use of human milk fortifiers is better than using them only when growth slows. Infants are randomly assigned to feeding groups, and their development is checked at age 2.

What this could mean

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

Active substance
pasteurized donor human milk and preterm formula
What this could lead to
If successful, this could identify the best feeding strategy to help very preterm infants survive without severe gut complications and support better brain development.
What could go wrong
This is an early-stage trial with no results yet. The benefits may be small or not apply to all infants, and feeding interventions carry risks like infection or intolerance.

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 2,324 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

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

1 day to 14 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: * Gestational age at birth less than 29 weeks; * No contraindications to enteral feeding; * Mother is willing to breastfeed. Exclusion Criteria: * For Randomization Group 1: If the infant has already received pasteurized human donor milk (pHDM), preterm formula (PTF), or nutritional fortifiers; * For Randomization Group 2: If the infant is exclusively fed with preterm formula and the mother has no intention to express breast milk;

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Conditions

The condition(s) this trial relates to.

necrotizing enterocolitis prevention target

As listed by the trial registrant

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

Necrotizing enterocolitis (NEC) Very preterm infant

How to take part

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

  1. The places running it

    22 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

  • Children's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 0571, China

  • Ganzhou Maternal and Child Health Hospital

    Ganzhou, Jiangxi, China

  • Hangzhou Women's Hospital

    Hangzhou, Zhejiang, 310008, China

  • Jiaxing Maternity and Child Health Care Hospital

    Jiaxing, Zhejiang, 314000, China

  • Nanyang Central Hospital

    Nanyang, Henan, 473000, China

  • Ningbo Women and Children's Hospital (The Affiliated Women and Children's Hospital of Ningbo University)

    Ningbo, Zhejiang, 315012, China

  • Peking University First Hospital Ningxia Women and Children's Hospital (Ningxia Hui Autonomous Region Maternal and Child Health Hospital)

    Yinchuan, Ningxia, China

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang Uygur Autonomous Region, China

  • Shandong Provincial Maternal and Child Health Care Hospital

    Jinan, Shandong, China

  • Sichuan Provincial Maternal and Child Health Hospital

    Chengdu, Sichuan, 610045, China

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016, China

  • The Affiliated Hospital of Guizhou Medical University

    Guizhou, Guiyang, 550001, China

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, China

  • The First Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The Second Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530007, China

  • Women's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310006, China

  • Yiwu Maternity and Child Health Care Hospital (Yiwu Branch of The Children's Hospital, Zhejiang University School of Medicine)

    Yiwu, Zhejiang, 322000, China

  • Yiyang Central Hospital

    Yiyang, Hunan, China

  • Yongkang Maternity and Child Health Care Hospital

    Guli, Zhejiang, 321300, China

  • Yulin Maternity and Child Health Care Hospital, Guangxi

    Yulin, Guangxi, 537000, China

More trials for these conditions

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