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

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ClinicalTrials.gov Identifier: NCT01534481
Recruitment Status : Active, not recruiting
First Posted : February 16, 2012
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network

Tracking Information
First Submitted Date  ICMJE February 13, 2012
First Posted Date  ICMJE February 16, 2012
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE August 2012
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2012)
Neurodevelopmental Outcome [ Time Frame: 22-26 months corrected age ]
As measured by scores on Bayley Scales of Infant Development III (BSID III)
Original Primary Outcome Measures  ICMJE
 (submitted: February 13, 2012)
Neurodevelopmental Outcome [ Time Frame: 18-22 months corrected age ]
As measured by scores on Bayley Scales of Infant Development III (BSID III)
Change History Complete list of historical versions of study NCT01534481 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2012)
  • 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
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2012)
  • 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
  • Growth outcomes [ Time Frame: 36 Weeks and 18-22 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.
  • Follow-up Outcomes [ Time Frame: 18-22 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
Official Title  ICMJE Neurodevelopmental Effects of Donor Human Milk vs. Preterm Formula in Extremely Low Birth Weight (ELBW) Infants
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Infant, Newborn
  • Infant, Small for Gestational Age
  • Infant, Extremely Low Birth Weight
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Donor Milk
    Donor milk provided by the Human Milk Banking Association of North America
    Intervention: Biological: Donor Milk
  • Placebo Comparator: Preterm Formula
    Preterm formula determined by center practice
    Intervention: Dietary Supplement: Preterm Formula
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 16, 2019)
483
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2012)
670
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 21 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01534481
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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 (https://dash.nichd.nih.gov)
Responsible Party NICHD Neonatal Research Network
Study Sponsor  ICMJE NICHD Neonatal Research Network
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
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
PRS Account NICHD Neonatal Research Network
Verification Date August 2019

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