Tailored milk boosts preemie brain growth?

NCT ID NCT03977259

Disease control Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two ways of fortifying breast milk for preterm babies in the NICU. One group gets standard fortification, while the other gets a personalized mix based on real-time milk analysis. Researchers will track growth, brain scans, and development up to age 2 to see which method works better.

What this could mean

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

Active substance: individualized human milk fortification with added protein and medium-chain triglycerides
What this could lead to: If successful, this approach could help preterm infants grow better and have healthier brain development, potentially reducing long-term developmental issues.
What could go wrong: This is a relatively small, early-stage study (130 infants) at a single hospital, so results may not apply broadly. The intervention is complex and may not show clear benefits over standard care.

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

130 people

The number who actually took part.

Started

Jan 2020

Expected to finish

Dec 2030

An estimate. End dates often move.

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

1 day to 21 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: * Inpatient in Brigham and Women's Hospital NICU * Gestational age 24 0/7 to 30 6/7 weeks * Chronologic age \<21 days * Mother providing breast milk Exclusion Criteria: * Major congenital anomaly * Severe fetal growth restriction (birth weight \<3rd percentile by Olsen reference) * Necrotizing enterocolitis, intestinal perforation, other major gastrointestinal pathology * Triplets or higher order multiples * Plan for redirection of care and/or anticipated death * Clinically significant renal or hepatic dysfunction * Inborn error of metabolism * Fluid restriction \<140 mL/kg/day for 3 or more days * Grade 3 or 4 intraventricular hemorrhage detected prior to enrollment * Anticipated transfer \<36 weeks' postmenstrual age * Parents do not consent to use of pasteurized donor human milk * Infant in non-parental custody

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Brain development abnormality are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Breast Milk Expression Infant Nutrition Disorders neurodevelopmental disorder nutritional disorder Premature Birth

As listed by the trial registrant

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

Brain development abnormality Breast milk expression Neurodevelopmental disorders Nutrition disorder, infant Preterm birth

Tailored milk boosts preemie brain growth?

What the study statuses mean