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

This study has been completed.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Tarah T Colaizy, University of Iowa Identifier:
First received: October 29, 2010
Last updated: May 26, 2016
Last verified: May 2016
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.

Condition Intervention Phase
Neurodevelopmental Outcomes of VLBW Infants
Dietary Supplement: Donor Human Milk
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Epidemiologic and Biologic Studies of Donor Human Milk and Breastfeeding

Resource links provided by NLM:

Further study details as provided by Tarah T Colaizy, University of Iowa:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Late Onset sepsis [ Time Frame: 4 months ]
    We will compare rates of in-hospital confirmed late onset sepsis in VLBW infants receiving donor human milk and preterm formula

  • length of hospital stay [ Time Frame: 4 months ]
    We will compare the length of initial hospital stay between infants who receive donor human milk and those who receive preterm infant formula

Enrollment: 121
Study Start Date: August 2009
Study Completion Date: May 2016
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Donor Human Milk
VLBW infants randomized to be fed donor human milk, fortified as appropriate, for all feedings for which maternal milk is not available, including infants who receive no maternal milk
Dietary Supplement: Donor Human Milk
Donor Human Milk, obtained from the Mother's Milk of Iowa, a HMBANA milk bank
Experimental: Preterm Formula
VLBW infants randomized to receive preterm infant formula for any feedings for which maternal milk is unavailable, including infants receiving no maternal milk
Dietary Supplement: Donor Human Milk
Donor Human Milk, obtained from the Mother's Milk of Iowa, a HMBANA milk bank


Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • <1501 g weight at birth

Exclusion Criteria:

  • chromosomal anomalies
  • congenital heart disease
  • congenital disorders known to impair neurodevelopment
  Contacts and Locations
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Please refer to this study by its identifier: NCT01232725

United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Tarah T Colaizy, MD, MPH University of Iowa
  More Information

Responsible Party: Tarah T Colaizy, Associate Professor of Pediatrics, University of Iowa Identifier: NCT01232725     History of Changes
Other Study ID Numbers: 200708746
K23HD057232 ( US NIH Grant/Contract Award Number )
Study First Received: October 29, 2010
Last Updated: May 26, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Contact PI to discuss data sharing

Keywords provided by Tarah T Colaizy, University of Iowa:
Human Milk
Donor Human Milk
Preterm infant
Breastfeeding processed this record on May 25, 2017