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Clinical Trials/NCT01232725
NCT01232725
Completed
Not Applicable

Clinical Epidemiologic and Biologic Studies of Donor Human Milk and Breastfeeding

Tarah T Colaizy1 site in 1 country121 target enrollmentAugust 2009

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.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
May 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Tarah T Colaizy
Responsible Party
Sponsor Investigator
Principal Investigator

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)

Study Sites (1)

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