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Can a Preemie's first diet protect their heart for life?

NCT ID NCT04413994

Prevention Sponsor: Prolacta Bioscience 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are studying whether feeding extremely preterm infants an exclusive human milk diet, with a fortifier made from human milk, affects early signs of blood vessel aging. The trial enrolls about 200 preterm babies weighing 500 to 1250 grams at birth and compares them with term-born children. The team measures blood sugar, blood pressure, and the flexibility of the aorta at ages one, two, and five to see if the type of milk fortifier used in the newborn period makes a lasting difference for heart health.

What this could mean

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

Active substance
an exclusive human milk diet with a human milk-based fortifier
What this could lead to
If it works, this could show that the first diet a preterm baby receives shapes heart and blood vessel health years later, giving hospitals a clear feeding choice to lower long-term cardiovascular risk.
What could go wrong
The trial follows children to age five, so any differences may be small or fade over time, and feeding choices in the NICU are only one of many factors that affect later heart health. Preterm infants face many other health challenges that could outweigh the effect of diet alone.

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 200 people

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

Started

Oct 2020

Expected to finish

Jun 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

1 day to 5 years

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.

Preterm-born group: Inclusion Criteria: 1. Extremely preterm infants with a birth weight of 500-1250g. 2. Feeding is NPO or exclusive human milk prior to enrollment. 3. Parent(s) willing to sign informed consent.- Exclusion Criteria: 1. Infants with a birth weight \<500g or \>1250g 2. Subjects diagnosed with inborn errors of metabolism such as galactosemia, phenylketonuria 3. Subjects who have not been NPO or fed exclusive human milk diet prior to enrollment. 4. Presence of major congenital malformation. 5. Presence of intestinal perforation or Stage 2 Necrotizing enterocolitis prior to enrollment. 6. Parent(s) not willing to sign informed consent. 7. Unable to participate for any reason based on the decision of the study investigator (e.g. unlikely to survive the study period). Term-born group: Inclusion criteria 1. Term-born children with an adequate birth weight 2. Parent(s) willing to sign informed consent Exclusion criteria 1. Subjects with acute or chronic illness 2. Parent(s) not willing to sign informed consent

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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.

Prematurity Vascular aging

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

  • Medical University of Innsbruck

    RECRUITING

    Innsbruck, Tyrol, A-6020, Austria

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