Hydrolized Protein Formula for Premature Infants
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Randomized Trial of Hydrolyzed Protein Premature Formula|
- Time to achieve full feeds [ Time Frame: Average 1 to 3 weeks of life ] [ Designated as safety issue: No ]Number of days from initiating oral feeds to achieve full feeds
- Postnatal days to achieve full feeds [ Time Frame: Average: 1- 3 weeks of age ] [ Designated as safety issue: No ]number of days from birth to achieve full feeds
|Study Start Date:||July 2010|
|Study Completion Date:||September 2015|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: Protein Hydrolyzed Formula
Infants assigned to this group will receive HP formula when breast milk not available or indicated to receive formula by the attending physician
Other: Protein Hydrolyzed Premature Formula
Infants will be fed with a protein hydrolyzed premature formula until they reach full feeds
No Intervention: Control
Infants in this group will receive standard prematrue formula when no breast milk available or indicated by the attending physician
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 time of enrollment all the eligible premature infants will be randomized and assigned to the study or control group. Infants will receive formula, either because breast milk is not available or because indicated by the attending physician and switched to formula, They will be fed, depending of the group to what they are assigned, with either the PH formula for the study group or regular premature formula for the control group.
Randomization and blinding All eligible infants with parental consent will be randomized to either the study group to receive protein hydrolyzed formula (PH group) or to the control group to receive standard premature formula. Randomization will be stratified by 2 birth weight categories (500-1000 g and 1001-1500 g). The purpose of such stratification is to avoid imbalance between groups for factors that may influence outcome and is based on the different morbidity in different birth weight categories.
Masked randomization will be performed in a way that avoids the possibility of knowledge of treatment assignment at the time that eligibility is assessed and consent is sought. Only the person in charge of preparing the control or study formula will be aware of the infant's assignment group. Caregivers will remain masked to treatment group.
Study population Preterm newborns admitted to the neonatal intensive care unit with a birth weight 500-1500 g and who survive more than 3 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156493
|United States, Florida|
|University of Miami/Holtz Children's Hospital/Neonatal Intensive Care Unit|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Teresa Del Moral, MD||University of Miami|