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Fat infusions could help preterm babies breathe easier and develop better
NCT ID NCT06915441
First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 5 times
Summary
This study compares two types of fat infusions (mixed oil vs. soybean oil) given to extremely preterm infants to improve nutrition and reduce the risk of bronchopulmonary dysplasia (a chronic lung disease) and neurodevelopmental impairment. About 230 babies born before 28 weeks or weighing under 1000 grams will receive one of the two infusions. The goal is to see which one leads to better survival without lung disease and better development at age two.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lipid emulsions (mixed oil or soybean oil)
- What this could lead to
- If it works, this could point toward a better way to feed extremely preterm babies, reducing their risk of chronic lung disease and developmental delays.
- What could go wrong
- This is a Phase 2 trial with 230 infants, so results are still early. The infusions may not show a clear benefit, and there are risks like infection or feeding intolerance.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 230 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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
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12 hours to 28 weeks
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * inborn \<28 weeks gestational age (GA) or ≤1000g birth weight (BW) * survives until 12 hours after birth. Exclusion Criteria: * Infants who are unable to be enrolled by 96 hours postnatal age * Major anomaly * Overt non-bacterial infection * Infants likely to expire soon defined as limiting or withdrawal of intensive care recommended or requested by the parents.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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The University of Texas Health Science Center at Houston
RECRUITINGHouston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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