Education and Training
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
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.
Stanford is currently accepting patients for this trial.
Intervention(s):
- biological: Donor Milk
- dietary supplement: Preterm Formula
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.
Ages Eligible for Study
N/A - 21 Days
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Krisa P. Van Meurs, MD
650-723-5711
I'm interested