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Human Milk Cream as a Caloric Supplement in Pre-Term Infants

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Prolacta Biosciences
Information provided by (Responsible Party):
Steve Abrams, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01487928
First received: December 5, 2011
Last updated: May 17, 2013
Last verified: May 2013
History of Changes
  Purpose

Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth. The investigators now have the ability to measure caloric density of human milk and add human milk cream to any human milk (mother's own or donor human milk) that is less than 20 kcal/oz to bring it up to that amount.


Condition Intervention
Prematurity
 Dietary Supplement: Human Milk Cream

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Randomized Study of the Use of Human Milk Cream as a Caloric Supplement in a Subset of Very Low Birth Weight Pre-Term Infants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Caloric content of human milk [ Time Frame: Daily until 36 weeks corrected gestational age ] [ Designated as safety issue: No ]
    Human milk samples will be analyzed for macronutrients and total caloric content.


Secondary Outcome Measures:
  • Growth [ Time Frame: Weekly until 36 weeks corrected age ] [ Designated as safety issue: No ]
    Growth (weight, length, and head circumference) will be evaluated weekly throughout the study


Estimated Enrollment: 78
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Human Milk Cream Group
For infants randomized to the human milk cream group, the human milk (either mother's own or donor) being provided to the infant will be tested each time a new container is used to prepare feedings. The test will be for the caloric content of the milk using a commercially available device provided for this purpose. If the caloric level falls below 20 kcal/oz for any test, then an appropriate amount of human milk cream will be added to the milk to bring the content as close as possible to 20 kcal/oz. The amount added will be calculated to the nearest mL rounding down for 0.1-0.4mL and up for 0.5-0.9 mL to avoid imprecision due to the measuring device used in the nutrition preparation area.
 Dietary Supplement: Human Milk Cream
If the caloric level of human milk (mother's own or donor) falls below 20 kcal/oz, then an appropriate amount of human milk cream will be added to the milk to bring the content as close as possible to 20 kcal/oz. For example, if the human milk is 19 kcal/oz, 2 mL of human milk cream will be added to 100mL of human milk.
No Intervention: Control Group
For infants randomized to the Control group, human milk and human milk derived fortifier will be provided according to the institutional standard of care and there will be no use of the milk analysis (mother's own or donor), which is typical for the vast majority of neonatal intensive care units.

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  Eligibility

Ages Eligible for Study:   up to 21 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Birth weight 750 - 1250g
  • Able to adhere to expected feeding protocol of mother's own milk/donor milk with fortification of Prolacta® fortifier
  • Reasonable expectation of survival
  • Enteral feeding must begin before the 21st day of life

Exclusion Criteria:

  • Decision to not start minimum enteral feed before day 21 of life
  • Unable to obtain informed consent from parent/guardian prior to the initiation of fortification of enteral feeding
  • Enrolled in any other clinical study affecting nutritional management during the study period
  • Presence of clinically significant congenital heart disease or major congenital malformations
  • Reasonable potential for early transfer to a non-study institution
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487928

Locations
United States, Texas
Baylor College of Medicine / Texas Children's Hospital
Houston, Texas, United States, 77030
UT Health Science Center, San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Baylor College of Medicine
Prolacta Biosciences
Investigators
Principal Investigator: Steven A Abrams, MD Baylor College of Medicine
  More Information

Publications:

Responsible Party: Steve Abrams, MD, Professor of Pediatrics, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01487928     History of Changes
Other Study ID Numbers: H-29743
Study First Received: December 5, 2011
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
breastfed
human milk cream
human milk fat
caloric supplement

ClinicalTrials.gov processed this record on June 18, 2013