Neurodevelopmental Effects of Donor Human Milk vs. Preterm Formula in ELBW Infants

Study ID
STU 022012-028

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Diana Vasil
214-648-3789
diana.vasil@utsouthwestern.edu

Principal Investigator
Myra Wyckoff

Summary

We will carry out a multicenter randomized trial of fortified donor human milk vs. preterm formula for ELBW infants receiving no or minimal maternal milk, to compare neurodevelopmental and health outcomes at 18-22 months. Premature infants weighing less than or equal to 1000 g at birth will be recruited from a subset of the centers of the NICHD Neonatal Research Network (NRN). The centers of the NRN care for approximately 1800 ELBW infants annually. Outcomes will be compared between infants randomized to be fed donor human milk vs. standard preterm formulas as the sole in-hospital diet if their mothers chose not to provide their own milk to their infants (no maternal milk) or are unable to provide at least 80% of all feedings as mother's milk at the time the infant is 21 days of age (minimal maternal milk).

The Primary Outcome will be neurodevelopmental outcome, as measured by scores on Bayley Scales of Infant Development III (BSID III). Secondary Outcome Variables include in Hospital Morbidities, death, late-onset sepsis/ meningitis, length of TPN use, length of initial hospital stay, necrotizing enterocolitis, bronchopulmonary dysplasia (BPD), necrotizing enterocolitis or death, BPD or death, and growth outcomes in the NICU and on follow-up. Follow-up Outcomes include number of hospital admissions between initial discharge and follow-up, motor and language scores on the BSID III, cerebral palsy, neurodevelopmental Impairment (NDI), profound Impairment, defined as BSID III Cognitive subscale score of 70, NDI or death, profound Impairment or death.

Participant Eligibility

-birth weight less than or equal 1000 grams
-infants may be inborn or admitted by transport prior to 7 days of age
-infant has survived for at least 12 hours