Hydrolized Protein Formula for Premature Infants

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Teresa del Moral, University of Miami
ClinicalTrials.gov Identifier:
NCT01156493
First received: July 1, 2010
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Prematurity
Other: Protein Hydrolyzed Premature Formula
Phase 2

Study Type: Interventional
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

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 118
Study Start Date: July 2010
Estimated Study Completion Date: January 2015
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 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.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156493

Locations
United States, Florida
University of Miami/Holtz Children's Hospital/Neonatal Intensive Care Unit
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Teresa Del Moral, MD University of Miami
  More Information

No publications provided

Responsible Party: Teresa del Moral, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01156493     History of Changes
Other Study ID Numbers: 20090579
Study First Received: July 1, 2010
Last Updated: November 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
feeding intolerance
prematurity

ClinicalTrials.gov processed this record on March 26, 2015