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…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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