Donor Human Milk and Neurodevelopmental Outcomes in Very Low Birthweight (VLBW) Infants
- Conditions
- Neurodevelopmental Outcomes of VLBW Infants
- Interventions
- Dietary Supplement: Donor Human Milk
- Registration Number
- NCT01232725
- Lead Sponsor
- Tarah T Colaizy
- Brief Summary
Breastfeeding is an important health-promoting behavior. Human milk is the ideal diet for all infants, optimizes intellect, and provides protection against infectious and atopic diseases in childhood as well as decreasing risks for obesity, hypertension and other chronic diseases. Infants with the highest risk of life-long disability, very low birthweight (VLBW) preterm infants, are breastfed at some of the lowest rates in the US. Maternal milk is not always available, and pasteurized donor human milk is an alternative that requires investigation. Whether donor milk conveys health and developmental advantages similar to those bestowed by maternal milk is unknown. By determining the effects of donor milk on health and developmental outcomes when compared to preterm infant formula, the investigators seek to optimize outcomes in this fragile population. The hypothesis of our donor milk research is that a donor human milk diet in non-maternal milk fed VLBW infants is associated with better neurodevelopmental outcome scores at 18-22 months adjusted age than a preterm infant formula diet.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
- <1501 g weight at birth
- chromosomal anomalies
- congenital heart disease
- congenital disorders known to impair neurodevelopment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Preterm Formula Donor Human Milk VLBW infants randomized to receive preterm infant formula for any feedings for which maternal milk is unavailable, including infants receiving no maternal milk Donor Human Milk Donor Human Milk VLBW infants randomized to be fed donor human milk, fortified as appropriate, for all feedings for which maternal milk is not available, including infants who receive no maternal milk
- Primary Outcome Measures
Name Time Method Cognitive scale score of the Bayley Scales of Infant Development, III 18 - 22 months' adjusted age We will administer the BSID III to all subjects at 18-22 mo of age, adjusted for prematurity. We will compare the scores between subjects who received donor human milk to those who received preterm infant formula
- Secondary Outcome Measures
Name Time Method Late Onset sepsis 4 months We will compare rates of in-hospital confirmed late onset sepsis in VLBW infants receiving donor human milk and preterm formula
length of hospital stay 4 months We will compare the length of initial hospital stay between infants who receive donor human milk and those who receive preterm infant formula
Trial Locations
- Locations (1)
University of Iowa
🇺🇸Iowa City, Iowa, United States