Milk volume showdown: which amount helps tiny preemies thrive?
NCT ID NCT06420531
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether giving very preterm babies (born 27-31 weeks) a higher or lower volume of human milk helps them grow healthier. About 486 infants will be tracked to see how their body composition and gut health respond. The goal is to find the best feeding plan for these fragile newborns.
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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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
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About 486 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Aug 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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6 hours to 4 days
- 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: * Gestational age between 27 0/7 and 31 6/7 weeks * Birthweight of 1500 grams or less * Human milk feeding during the first 14 days after birth * Full enteral feeding (120mL/kg/day or more) within the first 14 days after birth Exclusion Criteria: * Necrotizing enterocolitis stage 2 or greater * Spontaneous intestinal perforation * Major congenital/chromosomal anomalies * Terminal illness requiring limited or withheld support * Intention to restrict fluid intake after the first 14 postnatal days due to the presence of a symptomatic patent ductus arteriosus (PDA) * Any formula feeding within the first 14 days after birth
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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
4 sites. 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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University of Alabama at Birmingham
RECRUITINGBirmingham, Alabama, 35294, United States
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University of Mississippi Medical Center
NOT_YET_RECRUITINGJackson, Mississippi, 39216, United States
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University of Texas Health Science Center at Houston
NOT_YET_RECRUITINGHouston, Texas, 77030, United States
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University of Texas Southwestern Medical Center at Dallas
NOT_YET_RECRUITINGDallas, Texas, 75235, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a camera catch autism signs in preemie toddlers?
- Can gentle oscillations help premature babies breathe better?