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COMPLETED
NCT01534481
PHASE3

Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants

Sponsor: NICHD Neonatal Research Network

View on ClinicalTrials.gov

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.

Official title: Neurodevelopmental Effects of Donor Human Milk vs. Preterm Formula in Extremely Low Birth Weight (ELBW) Infants

Key Details

Gender

All

Age Range

Any - 21 Days

Study Type

INTERVENTIONAL

Enrollment

483

Start Date

2012-08

Completion Date

2021-11-30

Last Updated

2026-07-16

Healthy Volunteers

No

Interventions

BIOLOGICAL

Donor Milk

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

DIETARY_SUPPLEMENT

Preterm Formula

Preterm Formula determined by center practice.

Locations (17)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Stanford University

Palo Alto, California, United States

Emory University

Atlanta, Georgia, United States

Indiana University

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Wayne State University

Detroit, Michigan, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

University of New Mexico

Albuquerque, New Mexico, United States

University of Rochester

Rochester, New York, United States

RTI International

Durham, North Carolina, United States

Duke University

Durham, North Carolina, United States

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Research Institute at Nationwide Children's Hospital

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States