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Donor milk vs formula: which boosts breastfeeding in At-Risk newborns?

NCT ID NCT06315127

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study looks at whether giving pasteurized donor milk instead of formula to newborns who need extra feeding helps mothers breastfeed longer. It includes babies born small, late preterm, or to mothers with diabetes. About 112 infants will be randomly assigned to receive donor milk or formula during their hospital stay, and researchers will check breastfeeding rates at 4 months.

What this could mean

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

Active substance
pasteurized human donor milk
What this could lead to
If donor milk works better than formula, it could help more mothers breastfeed exclusively for longer, improving infant health.
What could go wrong
This is a small, early-stage trial with only 112 infants, so results may not apply broadly. Donor milk is safe but may not significantly improve breastfeeding rates.

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 112 people

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

Started

Feb 2024

Expected to finish

Jun 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.

Ages

Up to 2 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: Infants admitted to the well-baby unit at Sinai Health whose parent(s) intend to feed parent milk and who require supplementation: * Infants of gestational/ type 1/ type 2 diabetic mothers * Infants who are born small for gestational age (SGA) by using a sex-specific reference population and determining if their birth weight falls below the 10th percentile for gestational age * Infants with a birth weight less than 2.5 kg * Late preterm infants born between 35 0/7-36 6/7 weeks of gestational age Exclusion Criteria: * Enrollment in any other clinical study affecting nutritional management during the feeding intervention; anticipated change in primary caregiver (person providing the feed) prior to 4 months; refusal to consent to donor milk; supplementation with formula prior to enrollment; any physical condition that may impact growth (ex: skeletal dysplasia).

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Conditions

The condition(s) this trial relates to.

Breast Feeding diabetic embryopathy fetal growth restriction gestational diabetes type 1 diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

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

Gestational diabetes Late preterm infant Small for gestational age at delivery TYPE1DIABETES TYPE2DIABETES

Contacts and locations

Locations

  • Labour and Delivery at Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5, Canada

  • Maternal Fetal Medicine and Placenta clinics

    Toronto, Ontario, M5G 1Z5, Canada

  • Placenta Clinic

    Toronto, Ontario, M5G 1Z5, Canada

More trials for these conditions

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