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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party):

Tarah T Colaizy, University of Iowa

ClinicalTrials.gov Identifier:

NCT01232725

First received: October 29, 2010

Last updated: January 19, 2015

Last verified: January 2015

History of Changes

Purpose

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Clinical Epidemiologic and Biologic Studies of Donor Human Milk and Breastfeeding

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight Breastfeeding

U.S. FDA Resources

Further study details as provided by University of Iowa:

Primary Outcome Measures:

Cognitive scale score of the Bayley Scales of Infant Development, III [ Time Frame: 18 - 22 months' adjusted age ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
We will compare the length of initial hospital stay between infants who receive donor human milk and those who receive preterm infant formula


Estimated Enrollment:	80
Study Start Date:	August 2009
Estimated Study Completion Date:	July 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

Eligibility


Ages Eligible for Study:	up to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

<1501 g weight at birth

Exclusion Criteria:

chromosomal anomalies
congenital heart disease
congenital disorders known to impair neurodevelopment

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232725

Locations


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)

Investigators


Principal Investigator:	Tarah T Colaizy, MD, MPH	University of Iowa

More Information

No publications provided


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
Study First Received:	October 29, 2010
Last Updated:	January 19, 2015
Health Authority:	United States: Federal Government

Keywords provided by University of Iowa:


BSID III Human Milk Donor Human Milk Preterm infant Breastfeeding

ClinicalTrials.gov processed this record on February 27, 2015

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