Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01534481
First received: February 13, 2012
Last updated: September 26, 2013
Last verified: September 2013

February 13, 2012
September 26, 2013
August 2012
June 2017   (final data collection date for primary outcome measure)
Neurodevelopmental Outcome [ Time Frame: 22-26 months corrected age ] [ Designated as safety issue: Yes ]
As measured by scores on Bayley Scales of Infant Development III (BSID III)
Neurodevelopmental Outcome [ Time Frame: 18-22 months corrected age ] [ Designated as safety issue: Yes ]
As measured by scores on Bayley Scales of Infant Development III (BSID III)
Complete list of historical versions of study NCT01534481 on ClinicalTrials.gov Archive Site
  • In Hospital Morbidities [ Time Frame: Up to one year ] [ Designated as safety issue: Yes ]

    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
  • Growth outcomes [ Time Frame: 36 Weeks and 22-26 months corrected age ] [ Designated as safety issue: Yes ]
    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.
  • Follow-up Outcomes [ Time Frame: 22-26 months corrected age ] [ Designated as safety issue: Yes ]
    • 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
  • In Hospital Morbidities [ Time Frame: Up to one year ] [ Designated as safety issue: Yes ]

    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
  • Growth outcomes [ Time Frame: 36 Weeks and 18-22 months corrected age ] [ Designated as safety issue: Yes ]
    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.
  • Follow-up Outcomes [ Time Frame: 18-22 months corrected age ] [ Designated as safety issue: Yes ]
    • 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
Not Provided
Not Provided
 
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
Neurodevelopmental Effects of Donor Human Milk vs. Preterm Formula in Extremely Low Birth Weight (ELBW) Infants

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Infant, Newborn
  • Infant, Small for Gestational Age
  • Infant, Extremely Low Birth Weight
  • Biological: Donor Breast Milk
    Donor milk provided by the Human Milk Banking Association of North America
  • Dietary Supplement: Preterm Formula
    Preterm Formula determined by center practice.
  • Active Comparator: Donor Milk
    Intervention: Biological: Donor Breast Milk
  • Placebo Comparator: Preterm Formula
    Intervention: Dietary Supplement: Preterm Formula
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
670
June 2018
June 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Birth weight less than or equal to 1000 grams.
  • 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.
Both
up to 21 Days
No
Contact: Tarah Colaizy, MD, MPH 319-356-3508
Contact: Rosemary D Higgins, MD 301-496-5575
United States
 
NCT01534481
NICHD-NRN-0047, U10HD021364, U10HD040689, U10HD021385, U10HD027851, U10HD027853, U10HD027856, U10HD027904, U10HD027880, U10HD034216, U10HD021373, U10HD040492, U10HD053109, U10HD040461, U10HD068244, U10HD068263, U10HD068278, U10HD068284, U10HD036790
Yes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Research Resources (NCRR)
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: Ron N Goldberg, MD Duke University
Principal Investigator: Barbara J Stoll, MD Emory University
Principal Investigator: Brenda B Poindexter, MD, MS Indiana University
Principal Investigator: Abhik Das, PhD RTI International
Principal Investigator: Krisa P Van Meurs, MD Stanford University
Principal Investigator: Kurt Schibler, MD Cincinnati Children's Medical Center
Principal Investigator: Waldemar A Carlo, MD University of Alabama at Birmingham
Principal Investigator: Kristi L Watterberg, MD University of New Mexico
Principal Investigator: Pablo J Sanchez, MD University of Texas Southwestern Medical Center at Dallas
Principal Investigator: Kathleen A Kennedy, MD, MPH The University of Texas Health Science Center, Houston
Principal Investigator: Barbara Schmidt, MD University of Pennsylvania
Principal Investigator: Carl T D'Angio, MD University of Rochester
Principal Investigator: Leif Nelin, MD Research Institute at Nationwide Children's Hospital
Principal Investigator: William Truog, MD Children's Mercy Hospital-Kansas City, MO
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP