Human Milk Cream as a Caloric Supplement in Pre-Term Infants
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.
|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|
- 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.
- 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
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01487928
|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|
|Principal Investigator:||Steven A Abrams, MD||Baylor College of Medicine|