Status:
COMPLETED
Human Milk Cream as a Caloric Supplement in Pre-Term Infants
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Prolacta Bioscience
Conditions:
Prematurity
Eligibility:
All Genders
Up to 21 years
Phase:
NA
Brief Summary
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 infan...
Detailed Description
Once fortification (to either mother's or donor milk) is initiated and tolerance is established (based on clinical observation), infants will be randomized into one of two groups: to receive human mil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01487928
Start Date
December 1 2011
End Date
June 1 2015
Last Update
February 24 2025
Active Locations (2)
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1
Baylor College of Medicine / Texas Children's Hospital
Houston, Texas, United States, 77030
2
UT Health Science Center, San Antonio
San Antonio, Texas, United States, 78229