Neurodevelopmental Effects of Donor Human Milk vs. Preterm Formula in Extremely Low Birth Weight (ELBW) Infants
Who is this study for? Premature infants
Status: Completed
Location: See all (17) locations...
Intervention Type: Biological, Dietary supplement
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 21 days
Healthy Volunteers: f
View:
• Gestational age less than 29 weeks.
• Admitted to the NICU at less than or equal to 72 hours of life
• Survived at least 12 hours
Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
California
Stanford University
Palo Alto
Georgia
Emory University
Atlanta
Iowa
University of Iowa
Iowa City
Indiana
Indiana University
Indianapolis
Michigan
Wayne State University
Detroit
Missouri
Children's Mercy Hospital
Kansas City
North Carolina
Duke University
Durham
RTI International
Durham
New Mexico
University of New Mexico
Albuquerque
New York
University of Rochester
Rochester
Ohio
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland
Research Institute at Nationwide Children's Hospital
Columbus
Pennsylvania
University of Pennsylvania
Philadelphia
Rhode Island
Brown University, Women & Infants Hospital of Rhode Island
Providence
Texas
University of Texas Southwestern Medical Center at Dallas
Dallas
University of Texas Health Science Center at Houston
Houston
Time Frame
Start Date: 2012-08
Completion Date: 2021-11-30
Participants
Target number of participants: 483
Treatments
Active_comparator: Donor Milk
Donor milk provided by the Human Milk Banking Association of North America
Placebo_comparator: Preterm Formula
Preterm formula determined by center practice
Authors
Sponsors
Leads: NICHD Neonatal Research Network
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)