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

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.

Conditions

• Infant, Newborn
• Infant, Small for Gestational Age
• Infant, Extremely Low Birth Weight

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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Tarah Colaizy, MD, MPH · University of Iowa

• Michele C Walsh, MD · Case Western Reserve University, Rainbow Babies and Children's Hospital

• Seetha Shankaran, MD · Wayne State University

• Abbot R Laptook, MD · Brown University, Women & Infants Hospital of Rhode Island

• C. Michael Cotten, MD · Duke University

• David Carlton, MD · Emory University

• Greg Sokol, MD · Indiana University

• Abhik Das, PhD · RTI International

• Krisa P Van Meurs, MD · Stanford University

• Waldemar A Carlo, MD · University of Alabama at Birmingham

• Kristi L Watterberg, MD · University of New Mexico

• Myra Wyckoff, MD · University of Texas, Southwestern Medical Center at Dallas

• Jon Tyson, MD, MPH · The University of Texas Health Science Center, Houston

• Sara DeMauro, MD · University of Pennsylvania

• Carl T D'Angio, MD · University of Rochester

• Pablo J Sanchez, MD · Research Institute at Nationwide Children's Hospital

• William Truog, MD · Children's Mercy Hospital Kansas City

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Max Age

21 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-08-31

Primary Completion

2021-11-30

Completion

2021-11-30

Countries

• United States

Study Locations