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New device could replace Cow's milk fortifiers for preterm infants

NCT ID NCT07576972

Disease control Sponsor: Mother's Milk is Best 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a device that concentrates a mother's own milk to help preterm babies grow. About 310 infants born at 32-34 weeks will either get concentrated milk or standard fortified milk. The goal is to see if the concentrated milk works as well for growth and mineral levels, while being safer and cheaper.

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 310 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

32 to 35 weeks

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: * Birth at 32 0/7 to 34 5/7 weeks' gestational age, with a birthweight above 1500 grams and receiving MOM * Enteral feeding must be initiated within 48 hours post-birth and the infant must meet the NICU's clinical guidelines for feed fortification/supplementation. * Multiples are eligible and will be randomized to the same group since the intervention affects MOM preparation. Exclusion Criteria: * Major congenital anomalies * Contraindication to receiving MOM * Feeds not started by 2 days post-birth * Fortification/supplementation not ordered by 5 days post-birth, * Inadequate MOM for concentration/fortification within 5 days post-birth * Expected transfer to another hospital * Expected hospital discharge within 14 days post-birth * Enrollment in another intervention study with an intervention that could affect infant growth or mineral status * Infant with contraindications for use of the HMC device

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

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

Premature babies Preterm infant health

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

  • Yale University

    New Haven, Connecticut, 06511, United States

More trials for these conditions

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