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

Study ID

Cancer Related

Healthy Volunteers

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)
  • Parkland Health & Hospital System

Diana Vasil

Principal Investigator
Myra Wyckoff, M.D.

Official Title

Neurodevelopmental Effects of Donor Human Milk vs. Preterm Formula in Extremely Low Birth Weight (ELBW) Infants

Brief Overview

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.

Participant Eligibility

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.