Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
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| ClinicalTrials.gov Identifier: NCT01534481 |
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Recruitment Status :
Completed
First Posted : February 16, 2012
Results First Posted : February 6, 2023
Last Update Posted : February 6, 2023
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Sponsor:
NICHD Neonatal Research Network
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network
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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 |
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 : | 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 30, 2021 |
| Actual Study Completion Date : | November 30, 2021 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Donor Milk
Donor milk provided by the Human Milk Banking Association of North America
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Biological: Donor Milk
Donor milk provided by the Human Milk Banking Association of North America |
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Placebo Comparator: Preterm Formula
Preterm formula determined by center practice
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Dietary Supplement: Preterm Formula
Preterm Formula determined by center practice. |
Primary Outcome Measures :
- Bayley Scales of Infant Development (BSID) Cognitive Composite Score [ Time Frame: At 22-26 months corrected age ]Mean cognitive composite score (standardized mean 100, SD 15, range 54-145). Subjects who died prior to follow-up assigned the score of 54. (lower scores indicating greater impairment)
Secondary Outcome Measures :
- Total Deaths Before Discharge [ Time Frame: From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth ]Infant died before discharge home.
- Late Onset Sepsis (LOS) [ Time Frame: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth ]Number of infants diagnosed with LOS
- Necrotizing Enterocolitis (NEC) [ Time Frame: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth ]Number of infants diagnosed with NEC
- Death or Necrotizing Enterocolitis (NEC) [ Time Frame: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth ]A composite outcome that measures the occurrence of death or NEC
- Change in Weight-for-age Z-score During Study [ Time Frame: During Study Intervention, the time between study randomization and discontinuation of study protocol. Infants exited from the study protocol 1-2 weeks prior to anticipated hospital discharge or 120 days, whichever is sooner ]
Weight-for-age Z-scores were calculated at both baseline (study initiation) and study end (within one week of last study data collected) based on Fenton growth curves (2013). This outcome represents the change in weight-for-age Z-score during the course of the study (i.e., the Z-score at baseline was subtracted from the Z-score at study end).
A value of 0 represents that the infant's weight-for-age Z-score is the same at the beginning and the end of the study. Positive values indicate the increase in the infant's weight-for-age Z-score during the study; negative values indicate the decrease in the infant's weight-for-age Z-score during the study.
- Bayley Scales of Infant Development (BSID) Motor Composite Score [ Time Frame: At 22-26 months corrected age ]Mean motor composite score (standardized mean 100, range 44-155). Subjects who died prior to follow-up assigned the score of 44. (lower scores indicating greater impairment)
- Bayley Scales of Infant Development (BSID) Language Composite Score [ Time Frame: At 22-26 months corrected age ]Mean language composite score (standardized mean 100, range 46-155). Subjects who died prior to follow-up assigned the score of 46. (lower scores indicating greater impairment)
- Moderate to Severe Cerebral Palsy [ Time Frame: At 22-26 months corrected age ]Number of infants with moderate or severe grade of cerebral palsy
- Neurodevelopmental Impairment (NDI). [ Time Frame: At 22-26 months corrected age ]Number of infants with NDI. NDI is defined as any of the following: Gross Motor Function Classification System score greater than or equal to 2, Bayley III cognitive or motor score less than 85 (1 standard deviation), Vision Impairment or Hearing impairment
- Profound Impairment [ Time Frame: At 22-26 months corrected age ]Number of infants with profound impairment.
- Death or Neurodevelopmental Impairment (NDI) [ Time Frame: At 22-26 months corrected age ]A composite outcome that measures the occurrence of death through 22-26 months or NDI.
Information from the National Library of Medicine
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| Ages Eligible for Study: | up to 21 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 ClinicalTrials.gov identifier (NCT number): NCT01534481
Locations
Show 17 study locations
Sponsors and Collaborators
NICHD Neonatal Research Network
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
| 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 |
Study Documents (Full-Text)
Documents provided by NICHD Neonatal Research Network:
Documents provided by NICHD Neonatal Research Network:
Study Protocol and Statistical Analysis Plan [PDF] January 8, 2014
Additional Information:
Keywords provided by NICHD Neonatal Research Network:
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NICHD Neonatal Research Network Extremely Low Birth Weight (ELBW) Prematurity |
Neurodevelopmental Impairment Donor Breast Milk Preterm Formula |
Additional relevant MeSH terms:
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Body Weight Birth Weight |