An interventional study of Protein Hydrolyzed Premature Formula in Prematurity, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 3 Days to 6 Months. Per ClinicalTrials.gov, last updated 2017-05-10.
Sponsored by University of Miami · Not applicable, Interventional, and Prevention
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.
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.
2,557 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 137 is above the median of 84 across 1,691 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University of Miami is the lead sponsor of 821 studies on the registry; 162 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 in this group will receive standard prematrue formula when no breast milk available or indicated by the attending physician
Infants will be fed with a protein hydrolyzed premature formula until they reach full feeds
Time to achieve full feeds
Number of days from initiating oral feeds to achieve full feeds
Time frame: Average 1 to 3 weeks of life
Postnatal days to achieve full feeds
number of days from birth to achieve full feeds
Time frame: Average: 1- 3 weeks of age
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Miami