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

This study is currently recruiting participants.
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

October 29, 2010
November 1, 2010
August 2009
July 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01232725 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Donor Human Milk and Neurodevelopmental Outcomes in Very Low Birthweight (VLBW) Infants
Clinical Epidemiologic and Biologic Studies of Donor Human Milk and Breastfeeding

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Neurodevelopmental Outcomes of VLBW Infants
Dietary Supplement: Donor Human Milk
Donor Human Milk, obtained from the Mother's Milk of Iowa, a HMBANA milk bank
  • 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
    Intervention: Dietary Supplement: Donor Human Milk
  • 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
    Intervention: Dietary Supplement: Donor Human Milk
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
July 2016
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • <1501 g weight at birth

Exclusion Criteria:

  • chromosomal anomalies
  • congenital heart disease
  • congenital disorders known to impair neurodevelopment
Both
up to 24 Months
No
Contact: Tarah T Colaizy, MD, MPH 319-356-3508 tarah-colaizy@uiowa.edu
United States
 
NCT01232725
200708746, K23HD057232
Yes
Tarah Colaizy, MD, MPH, University of Iowa
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
University of Iowa
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP