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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2010 by University of Iowa
Sponsor:
Collaborator:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT01232725
First received: October 29, 2010
Last updated: November 1, 2010
Last verified: October 2010
  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:


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
Estimated Primary Completion Date: July 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

Contacts
Contact: Tarah T Colaizy, MD, MPH 319-356-3508 tarah-colaizy@uiowa.edu

Locations
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Tarah Colaizy, MD, MPH    319-356-3508      
Principal Investigator: Tarah T Colaizy, MD, MPH         
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Tarah T Colaizy, MD, MPH University of Iowa
  More Information

No publications provided

Responsible Party: Tarah Colaizy, MD, MPH, University of Iowa
ClinicalTrials.gov Identifier: NCT01232725     History of Changes
Other Study ID Numbers: 200708746, K23HD057232
Study First Received: October 29, 2010
Last Updated: November 1, 2010
Health Authority: United States: National Government

Keywords provided by University of Iowa:
BSID III
Human Milk
Donor Human Milk
Preterm infant
Breastfeeding

ClinicalTrials.gov processed this record on October 01, 2014