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

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ClinicalTrials.gov Identifier: NCT01232725
Recruitment Status : Completed
First Posted : November 2, 2010
Last Update Posted : August 4, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Neurodevelopmental Outcomes of VLBW Infants Dietary Supplement: Donor Human Milk

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Epidemiologic and Biologic Studies of Donor Human Milk and Breastfeeding
Study Start Date : August 2009
Primary Completion Date : December 2014
Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01232725

United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Tarah T Colaizy
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
ClinicalTrials.gov Identifier: NCT01232725     History of Changes
Other Study ID Numbers: 200708746
K23HD057232 ( U.S. NIH Grant/Contract )
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
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