Donor Human Milk and Neurodevelopmental Outcomes in Very Low Birthweight (VLBW) Infants
Completed · Not applicable
Conditions studied: Neurodevelopmental Outcomes of VLBW Infants
In brief
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.
Key facts
- Study ID
- NCT01232725
- Run by
- Tarah T Colaizy
- People needed
- 121
- Starts
- 2009-08-01
- Expected to finish
- 2016-05-01
- Last updated by the study team
- 2017-08-04
Who can join
Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- <1501 g weight at birth
You may not qualify if…
- chromosomal anomalies
- congenital heart disease
- congenital disorders known to impair neurodevelopment
Where it is running
- University of Iowa — Iowa City, Iowa, United States
Full record on ClinicalTrials.gov
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