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NICU donor milk study checks if guidelines are being followed

NCT ID NCT01204983

Knowledge-focused Sponsor: Baylor College of Medicine Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how very low birth weight babies (under 1250 grams) are fed donor human milk in the NICU at Texas Children's Hospital. The goal was to see if current feeding practices follow hospital guidelines, especially for monitoring electrolyte levels. Researchers wanted to make sure that problems like high phosphorus or low sodium are caught and treated early. The study did not test a new treatment but checked how well existing care standards are working.

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.

Participants

About 150 people

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

Started

Jul 2010

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.

Who is studied

Premature, very low birth weight infants only

Ages

1 day and older

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: * Premature infants (\<37 weeks gestation) with a birth weight less than or equal to 1250 grams. Exclusion Criteria: * Infants with a birth weight greater than 1250 grams * Infants transferred from an outside hospital to TCH at greater than 21 days of age * Infants who do not achieve any enteral feeds by 4 weeks of age * Infants with major congenital anomalies

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As listed by the trial registrant

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

Infant, very low birth weight

Contacts and locations

Locations

  • Baylor College of Medicine / Texas Children's Hospital

    Houston, Texas, 77030, United States

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