NCT01232725

Donor Human Milk and Neurodevelopmental Outcomes in Very Low Birthweight (VLBW) Infants

Clinical Epidemiologic and Biologic Studies of Donor Human Milk and Breastfeeding

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Tarah T Colaizy · Academic / Other
• Sex: All
• Age: 24 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Neurodevelopmental Outcomes of VLBW Infants

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Donor Human Milk	Donor Human Milk, obtained from the Mother's Milk of Iowa, a HMBANA milk bank

Timeline

• Start date: 2009-08-01
• Primary completion: 2014-12-01
• Completion: 2016-05-01
• First posted: 2010-11-02
• Last updated: 2017-08-04

Locations

1 site across 1 country: United States