Human Milk Cream as a Caloric Supplement in Pre-Term Infants
Completed · Not applicable
Conditions studied: Prematurity
In brief
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.
Key facts
- Study ID
- NCT01487928
- Run by
- Baylor College of Medicine
- People needed
- 78
- Starts
- 2011-12-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2026-01-29
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Baylor College of Medicine / Texas Children's Hospital — Houston, Texas, United States
- UT Health Science Center, San Antonio — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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