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Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term

This study has been completed.
Sponsor:
Information provided by:
PBM Products
ClinicalTrials.gov Identifier:
NCT00936637
First received: July 8, 2009
Last updated: July 9, 2009
Last verified: July 2009
History of Changes
  Purpose

The purpose of this study is to assess growth in infants who are fed an extensively hydrolyzed formula.


Condition Intervention
Growth
 Other: Extensively hydrolyzed infant formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Official Title: A 16-Week Growth Study of an Extensively Hydrolyzed Infant Formula, 3 Months Treatment and 1 Month Follow-up for a Duration of 4 Months.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by PBM Products:

Primary Outcome Measures:
  • An extensively hydrolyzed formula is nutritionally adequate for normal growth of healthy full-term infants [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extensively hydrolyzed infant formula Other: Extensively hydrolyzed infant formula

  Eligibility

Ages Eligible for Study:   up to 21 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At birth:

    • Healthy, term (37-42 weeks) infant
    • Weight for length between the 10th and 90th percentile according to the National Center for Health Statistics (NCHS) growth charts

  • At time of enrollment:

    • < or = 21 days post-natal age
    • Weight for length between the 10th and 90th percentile according to the National Center for Health Statistics (NCHS) growth charts
    • Exclusively formula fed
    • Written informed consent of parent/guardian

Exclusion Criteria:

  • At the time of enrollment: partially human-milk fed; fed baby/solid foods
  • Conditions requiring feedings other than those specified in the protocol
  • Documented or suspected cow's milk allergy and/or soy protein allergies
  • Major congenital deformities
  • Suspected or documented systemic or congenital infections
  • Evidence of cardiac, respiratory, hematological, gastrointestinal, or other systemic diseases
  • Participation in any other clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00936637

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
PBM Products
Investigators
Study Director: Cynthia M Barber, PhD PBM Products
  More Information

No publications provided

Responsible Party: Cynthia Barber, PhD; Vice President of Regulatory, Medical and Clinical Affairs, PBM Products
ClinicalTrials.gov Identifier: NCT00936637     History of Changes
Other Study ID Numbers: UVA Growth Study
Study First Received: July 8, 2009
Last Updated: July 9, 2009
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 21, 2013