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Creamy addition to preemie diets may shorten hospital stays

NCT ID NCT02475434

Disease control Sponsor: Baylor College 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether adding a cream made from human milk to the standard feeding of extremely premature babies (birth weight 500-1250 grams) could help them leave the hospital earlier. 210 infants were randomly assigned to get either the cream supplement or standard care. The main goal was to see if the cream shortened hospital stays, especially for babies with a lung condition called bronchopulmonary dysplasia.

What this could mean

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

Active substance
human milk cream (ProlactCR)
What this could lead to
If it works, this could become a standard way to help extremely premature babies, especially those with lung problems, go home earlier.
What could go wrong
This is a completed study, but results may not apply to all hospitals or babies. The cream is a dietary supplement, not a drug, so benefits may be modest.

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

210 people

The number who actually took part.

Started

Jun 2015

Finished

Dec 2025

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 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: * Birth weight 500-1250g. * Must be likely to be able to adhere to a feeding protocol involving mother's own milk/donor milk that will include fortification using HM-based product (Prolact+H2MF®) and, potentially, human milk-based cream supplement. * Enteral feeding must begin before day 14 of life and parenteral nutrition must be started by day 2 of life. * Informed consent obtained from parent or legal guardian prior to reaching 100 ml/kg/day of fortified feeds. Consent should be obtained as soon as possible for eligible infants to collect tracheal aspirates (if intubated) and meconium stool. However, consent must be obtained prior to reaching 100 ml/kg/day of fortified feeds because this is when randomization will occur. Exclusion Criteria: * Unlikely to survive the study period. * Enrolled in another clinical study affecting nutritional management during the study period. * Decision to not start minimum enteral feed before day 14 of life or parenteral nutrition before day 2 of life. * Presence of clinically significant congenital heart disease or other major congenital malformation. * Presence prior to enrollment of intestinal perforation or Stage 2 Necrotizing enterocolitis prior to tolerating fortified feeds. * Reasonable likelihood of early transfer to a non-study institution. * Unable to participate for any reason based on the decision of the study investigator.

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Conditions

The condition(s) this trial relates to.

bronchopulmonary dysplasia Premature Birth

As listed by the trial registrant

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

Bronchopulmonary dysplasia

Contacts and locations

Locations

  • Baylor College of Medicine / Texas Children's Hospital

    Houston, Texas, 77030, United States

  • Children's Hospital Medical Center of Akron

    Boardman, Ohio, 44512, United States

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104, United States

  • Michigan State University

    East Lansing, Michigan, 48824, United States

  • Orlando Health, Inc. - Winnie Palmer Hospital for Women and Babies

    Orlando, Florida, 32806, United States

  • University Hospital

    Innsbruck, 6020, Austria

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900, United States

  • Wasatch Neonatal

    Orem, Utah, 84057, United States

More trials for these conditions

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