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Hydrolized Protein Formula for Premature Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Miami.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT01156493
First received: July 1, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  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)
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: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Protein Hydrolyzed Formula Other: Protein Hydrolyzed Premature Formula
Infants will be fed with a protein hydrolyzed premature formula until they reach full feeds

  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

Contacts
Contact: Lina Maichel, MD 3055856408 LMaichel@med.miami.edu

Locations
United States, Florida
University of Miami/Holtz Children's Hospital/Neonatal Intensive Care Unit Not yet recruiting
Miami, Florida, United States, 33136
Contact: Teresa del Moral, MD    305-585-6408    tdelmoral@miami.edu   
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, MD/ Associate Professor of Pediatrics Division of Neonatology, University of Miami
ClinicalTrials.gov Identifier: NCT01156493     History of Changes
Other Study ID Numbers: 20090579
Study First Received: July 1, 2010
Last Updated: July 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
feeding intolerance
prematurity

ClinicalTrials.gov processed this record on November 20, 2014