Status:
COMPLETED
Hydrolized Protein Formula for Premature Infants
Lead Sponsor:
University of Miami
Conditions:
Prematurity
Eligibility:
All Genders
3-6 years
Phase:
NA
Brief Summary
Premature infants fed with a protein hydrolyzed formula will have better tolerance needing shorter time to achieve full feeds when compared to those fed with an intact protein formula.
Detailed Description
The study formula is a 100% whey protein partially hydrolyzed (vs 60/40 Whey:Casein ratio of regular premature formulas) Because the tolerance and availability of breast milk is not predictable at the...
Eligibility Criteria
Inclusion
- Birth weight between 500 -1500g and \< 32 weeks GA who survive more than 3 days.
- Has not yet started enteral full feeds.
- Study explained and parent/caregiver demonstrating understanding of the given information.
- Informed consent signed.
Exclusion
- Chromosomal anomalies.
- Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia).
- Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention.
- Parental refusal.
- Prior enrollment into a conflicting clinical trial. Conflicting clinical trial will be those in which the intervention could modify the outcome of the present study, for example studies aimed to accelerate feeds and or improve tolerance.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT01156493
Start Date
July 1 2010
End Date
September 1 2015
Last Update
May 10 2017
Active Locations (1)
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1
University of Miami/Holtz Children's Hospital/Neonatal Intensive Care Unit
Miami, Florida, United States, 33136