Phase 3
Completed N=483
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
Infant, Newborn · Infant, Small for Gestational Age · Infant, Extremely Low Birth Weight
Source: ClinicalTrials.gov NCT01534481 ↗
Enrolled (actual)
483
Serious AEs
19.7%
Results posted
Feb 2023
Primary outcomePrimary: Bayley Scales of Infant Development (BSID) Cognitive Composite Score — 80.7; 81.1 Score on a scale
◆ Published Evidence
Established
65citations · ~33 / year
Neurodevelopmental Outcomes of Extremely Preterm Infants Fed Donor Milk or Preterm Infant Formula: A Randomized Clinical Trial.
Summary
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.
Linked Publications
-
Neurodevelopmental Outcomes of Extremely Preterm Infants Fed Donor Milk or Preterm Infant Formula: A Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bayley Scales of Infant Development (BSID) Cognitive Composite Score |
80.7; 81.1 | — |
| SECONDARY Total Deaths Before Discharge |
24; 18; 215; 226 | — |
| SECONDARY Late Onset Sepsis (LOS) |
1; 0; 47; 37; 191; 207 | — |
| SECONDARY Necrotizing Enterocolitis (NEC) |
10; 22; 229; 222 | — |
| SECONDARY Death or Necrotizing Enterocolitis (NEC) |
27; 33; 212; 211 | — |
| SECONDARY Change in Weight-for-age Z-score During Study |
-0.4; -0.1 | — |
| SECONDARY Bayley Scales of Infant Development (BSID) Motor Composite Score |
80.3; 80.1 | — |
| SECONDARY Bayley Scales of Infant Development (BSID) Language Composite Score |
76.7; 75.8 | — |
| SECONDARY Moderate to Severe Cerebral Palsy |
3; 2; 14; 20; 171; 177 | — |
| SECONDARY Neurodevelopmental Impairment (NDI). |
11; 10; 89; 98; 88; 91 | — |
| SECONDARY Profound Impairment |
4; 5; 154; 152; 30; 42 | — |
| SECONDARY Death or Neurodevelopmental Impairment (NDI) |
11; 10; 118; 123; 88; 91 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01534481) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.