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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01534481
Recruitment Status : Completed
First Posted : February 16, 2012
Last Update Posted : November 22, 2021
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network

Brief 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.

Condition or disease Intervention/treatment Phase
Infant, Newborn Infant, Small for Gestational Age Infant, Extremely Low Birth Weight Biological: Donor Milk Dietary Supplement: Preterm Formula Phase 3

Detailed Description:
There is strong evidence that maternal breast milk feedings in infancy confer multiple health benefits in the extremely preterm population (extremely low birth weight, ELBW, <1000 g). Studies suggest an IQ advantage of up to 8 points conferred by maternal milk feeding in this population. Rates of sepsis and necrotizing enterocolitis are also lower in human milk fed ELBW infants, and they experience shorter hospital stays and fewer re-hospitalizations in the first year of life. When mothers choose not to or are unable to provide milk, preterm formula is usually used. Recently, pasteurized donor human milk is available in some NICUs in the US as an alternative to preterm formula. Donor milk has not been well studied with regard to its safety and efficacy. It is unknown if donor human milk confers the same benefits as maternal milk with regard to neurodevelopmental and health outcomes. The proposed study will be the first US multicenter randomized trial of the health and developmental effects of donor milk as compared to preterm formula in ELBW infants receiving little or no maternal milk. Our long-term goal is to optimize neurodevelopmental and health outcomes for ELBW infants, maximizing their quality of life and societal functionality throughout their lives. If donor human milk has similar effects to maternal milk, the public health benefit of donor milk feedings in ELBW infants unable to receive maternal milk would be considerable.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 483 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Neurodevelopmental Effects of Donor Human Milk vs. Preterm Formula in Extremely Low Birth Weight (ELBW) Infants
Actual Study Start Date : August 2012
Actual Primary Completion Date : November 15, 2021
Actual Study Completion Date : November 15, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Donor Milk
Donor milk provided by the Human Milk Banking Association of North America
Biological: Donor Milk
Donor milk provided by the Human Milk Banking Association of North America

Placebo Comparator: Preterm Formula
Preterm formula determined by center practice
Dietary Supplement: Preterm Formula
Preterm Formula determined by center practice.

Primary Outcome Measures :
  1. Neurodevelopmental Outcome [ Time Frame: 22-26 months corrected age ]
    As measured by scores on Bayley Scales of Infant Development III (BSID III)

Secondary Outcome Measures :
  1. In Hospital Morbidities [ Time Frame: Up to one year ]

    These include:

    • Death
    • Late onset sepsis or meningitis
    • Length of TPN use
    • Length of initial hospital stay
    • Necrotizing enterocolitis
    • Bronchopulmonary dysplasia (BPD), defined as room air oxygen saturation of less than 90% at 36 weeks postmenstrual age using the NRN standard physiologic definition of BPD.
    • Necrotizing enterocolitis or death
    • BPD or death

  2. Growth outcomes [ Time Frame: 36 Weeks and 22-26 months corrected age ]
    In-Hospital growth parameters, including rate of weight gain, weight, length and head circumference at 36 weeks or discharge, whichever comes first. Weights will be obtained from hospital records weekly, length and head circumference will be measured bi-weekly by study personnel.

  3. Follow-up Outcomes [ Time Frame: 22-26 months corrected age ]
    • Number of hospital admissions between initial discharge and follow-up
    • Motor and Language scores on the BSID III
    • Cerebral Palsy
    • Neurodevelopmental Impairment (NDI), using current Follow-Up Study definition.
    • Profound Impairment, defined as BSID III Cognitive subscale score of 70
    • NDI or death
    • Profound Impairment or death

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 21 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Chromosomal anomalies
  • Cyanotic congenital heart disease
  • Diagnosed intrauterine infection
  • Other congenital disorders known to impair neurodevelopment
  • NEC or IP prior to seeking consent
  • Decision documented to limit intensive care therapies
  • Congenital disorders that may affect feeding

Feeding Group Eligibility:

  • Sole Diet Group: Infants will be eligible for the sole diet feeding protocol if the mother declines to provide breast milk for the baby.
  • Supplemental Diet (minimal maternal milk) Group: Infants whose mothers initially choose to provide breast milk and begin pumping will be re-screened for eligibility at least weekly until the infant is 21 days old. If the mother stops expressing milk at any point prior to the infant's 21st day of life, her infant will be eligible for randomization. In addition, those whose mothers are providing less than 20% of the infant's dietary needs (averaged over past 5 days) when the infant reaches 21 days of age will be eligible for randomization at this point. No infant will be randomized after reaching 21 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01534481

Show Show 17 study locations
Sponsors and Collaborators
NICHD Neonatal Research Network
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Study Director: Tarah Colaizy, MD, MPH University of Iowa
Principal Investigator: Michele C Walsh, MD Case Western Reserve University, Rainbow Babies and Children's Hospital
Principal Investigator: Seetha Shankaran, MD Wayne State University
Principal Investigator: Abbot R Laptook, MD Brown University, Women & Infants Hospital of Rhode Island
Principal Investigator: C. Michael Cotten, MD Duke University
Principal Investigator: David Carlton, MD Emory University
Principal Investigator: Greg Sokol, MD Indiana University
Principal Investigator: Abhik Das, PhD RTI International
Principal Investigator: Krisa P Van Meurs, MD Stanford University
Principal Investigator: Waldemar A Carlo, MD University of Alabama at Birmingham
Principal Investigator: Kristi L Watterberg, MD University of New Mexico
Principal Investigator: Myra Wyckoff, MD University of Texas, Southwestern Medical Center at Dallas
Principal Investigator: Jon Tyson, MD, MPH The University of Texas Health Science Center, Houston
Principal Investigator: Sara DeMauro, MD University of Pennsylvania
Principal Investigator: Carl T D'Angio, MD University of Rochester
Principal Investigator: Pablo J Sanchez, MD Research Institute at Nationwide Children's Hospital
Principal Investigator: William Truog, MD Children's Mercy Hospital Kansas City
Additional Information:
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Responsible Party: NICHD Neonatal Research Network Identifier: NCT01534481    
Other Study ID Numbers: NICHD-NRN-0047
U10HD021364 ( U.S. NIH Grant/Contract )
U10HD040689 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
U10HD027851 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
U10HD027856 ( U.S. NIH Grant/Contract )
U10HD027904 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
U10HD034216 ( U.S. NIH Grant/Contract )
U10HD021373 ( U.S. NIH Grant/Contract )
U10HD040492 ( U.S. NIH Grant/Contract )
U10HD053109 ( U.S. NIH Grant/Contract )
U10HD040461 ( U.S. NIH Grant/Contract )
U10HD068244 ( U.S. NIH Grant/Contract )
U10HD068263 ( U.S. NIH Grant/Contract )
U10HD068278 ( U.S. NIH Grant/Contract )
U10HD068284 ( U.S. NIH Grant/Contract )
U10HD036790 ( U.S. NIH Grant/Contract )
First Posted: February 16, 2012    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NIH has had a long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds. The NRN plans to share de-identified data after final publication in an NIH supported data repository such as the NICHD Data and Specimen Hub (
Keywords provided by NICHD Neonatal Research Network:
NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Neurodevelopmental Impairment
Donor Breast Milk
Preterm Formula
Additional relevant MeSH terms:
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Body Weight
Birth Weight