Hydrolized Protein Formula for Premature Infants

Completed · Not applicable

Conditions studied: Prematurity

In brief

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.

Key facts

Study ID

NCT01156493

Run by

University of Miami

People needed

137

Starts

2010-07-01

Expected to finish

2015-09-01

Last updated by the study team

2017-05-10

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Miami/Holtz Children's Hospital/Neonatal Intensive Care Unit — Miami, Florida, United States

Full record on ClinicalTrials.gov

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