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

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.

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.