CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 483 enrolled
Drug / intervention
Donor Milk +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01534481
NCT01534481Phase 3Completed
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Neurodevelopmental Effects of Donor Human Milk vs. Preterm Formula in Extremely Low Birth Weight (ELBW) Infants

NICHD Neonatal Research Network·interventional·Posted Feb 16, 2012·Updated Feb 6, 2023

In Brief

A Phase 3 clinical trial evaluating Donor Milk and Preterm Formula for Infant, Newborn and 2 related conditions. Completed, enrolled 483 participants across 17 sites.

Detailed Summary

The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26 months of donor human milk as compared to preterm infant formula as the in-hospital diet for infants whose mothers choose not to provide breast milk or are able to provide only a minimal amount. Infants will be randomized to receive donor breast milk or formula during their hospital stay. Infant's will be followed until they reach 22-26 months of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfant, Newborn, Infant, Small for Gestational Age, Infant, Extremely Low Birth Weight
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 16, 2012
Enrollment StartAug 1, 2012
Primary CompletionNov 30, 2021
TodayJul 1, 2026
Enrollment to primary: 9.3 yearsPosted 14.4 years ago

Interventions

Donor Milkbiological

Donor milk provided by the Human Milk Banking Association of North America

Preterm Formuladietary

Preterm Formula determined by center practice.