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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

483 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2021-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Donor Milk

Donor milk provided by the Human Milk Banking Association of North America

Group Type ACTIVE_COMPARATOR

Donor Milk

Intervention Type BIOLOGICAL

Donor milk provided by the Human Milk Banking Association of North America

Preterm Formula

Preterm formula determined by center practice

Group Type PLACEBO_COMPARATOR

Preterm Formula

Intervention Type DIETARY_SUPPLEMENT

Preterm Formula determined by center practice.

Interventions

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Donor Milk

Donor milk provided by the Human Milk Banking Association of North America

Intervention Type BIOLOGICAL

Preterm Formula

Preterm Formula determined by center practice.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Maximum Eligible Age

21 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No