Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01232725
Recruitment Status : Completed
First Posted : November 2, 2010
Last Update Posted : August 4, 2017
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

Tracking Information
First Submitted Date  ICMJE October 29, 2010
First Posted Date  ICMJE November 2, 2010
Last Update Posted Date August 4, 2017
Study Start Date  ICMJE August 2009
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2010)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2010)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Donor Human Milk and Neurodevelopmental Outcomes in Very Low Birthweight (VLBW) Infants
Official Title  ICMJE Clinical Epidemiologic and Biologic Studies of Donor Human Milk and Breastfeeding
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neurodevelopmental Outcomes of VLBW Infants
Intervention  ICMJE Dietary Supplement: Donor Human Milk
Donor Human Milk, obtained from the Mother's Milk of Iowa, a HMBANA milk bank
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2016)
121
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2010)
80
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • <1501 g weight at birth

Exclusion Criteria:

  • chromosomal anomalies
  • congenital heart disease
  • congenital disorders known to impair neurodevelopment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 24 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01232725
Other Study ID Numbers  ICMJE 200708746
K23HD057232 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Contact PI to discuss data sharing
Responsible Party Tarah T Colaizy, University of Iowa
Study Sponsor  ICMJE Tarah T Colaizy
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Tarah T Colaizy, MD, MPH University of Iowa
PRS Account University of Iowa
Verification Date August 2017

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