Clinical Epidemiologic and Biologic Studies of Donor Human Milk and Breastfeeding
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neurodevelopmental Outcomes of VLBW Infants
- Sponsor
- Tarah T Colaizy
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Cognitive scale score of the Bayley Scales of Infant Development, III
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Tarah T Colaizy
Associate Professor of Pediatrics
University of Iowa
Eligibility Criteria
Inclusion Criteria
- •\<1501 g weight at birth
Exclusion Criteria
- •chromosomal anomalies
- •congenital heart disease
- •congenital disorders known to impair neurodevelopment
Outcomes
Primary Outcomes
Cognitive scale score of the Bayley Scales of Infant Development, III
Time Frame: 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 Outcomes
- Late Onset sepsis(4 months)
- length of hospital stay(4 months)