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Donor milk may keep newborns out of ICU

NCT ID NCT06993103

Disease control Sponsor: The University of Queensland Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This study tests whether giving pasteurized donor human milk to full-term babies of mothers with diabetes during the first five days of life can reduce the number of infants admitted to the neonatal unit for low blood sugar. About 1,444 mothers and their newborns will be randomly assigned to receive either donor milk as a supplement or standard hospital care. Researchers will also track breastfeeding success, maternal mental health, and cow's milk allergy symptoms.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,444 people

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

Started

Dec 2025

Expected to finish

Dec 2028

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 48 hours

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: Each participant must meet all the following criteria to be enrolled in this trial: * Mother is \>18 years at the time of consent * Mother has diabetes in pregnancy (type 1, type 2 or gestational diabetes) * Mother intends to breastfeed for at least 6 weeks at the time of consent. * Infant is born at ≥ 37 weeks and weighs \> 2.5kg * Clinician caring for infant decides that supplementary nutrition (in addition to maternal breast milk) is required within the first 48 hours after birth. * Parent/s provide/s a signed and dated informed consent form and has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf. Exclusion Criteria: Mother/infant pairs meeting any of the following criteria will be excluded from the trial: * Multiple pregnancy * Mother has a condition that precludes maternal breast milk consumption e.g. HIV, receiving chemotherapy * Infant has clinically significant congenital abnormality interfering with effective breastfeeding or breast milk consumption (e.g., cleft lip and palate, metabolic disorder) and/or requiring immediate care in a neonatal unit (e.g., congenital heart disease). * Infant has received infant formula prior to randomisation. * Infant admitted to neonatal intensive care prior to randomisation. * More than 48 hours old at the time of recruitment

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Conditions

The condition(s) this trial relates to.

Breast Feeding gestational diabetes Heiner syndrome mental disorder metabolic disease Milk Hypersensitivity

As listed by the trial registrant

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

Breastfeeding Cows milk allergy Hospital length of stay Mental health issue Metabolic complication Neonatal hypoglycemia Neonatal intensive care unit

How to take part

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

  1. The places running it

    4 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

  • Frances Perry House (VIC)

    RECRUITING

    Melbourne, Victoria, Australia

  • Greenslope Hospital (QLD)

    NOT_YET_RECRUITING

    Brisbane, Queensland, 4101, Australia

  • Royal Brisbane and Womens Hospital (QLD)

    NOT_YET_RECRUITING

    Brisbane, Queensland, 4010, Australia

  • Royal Womens Hospital (VIC)

    RECRUITING

    Melbourne, Victoria, Australia

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