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
  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:


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
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: 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 October 01, 2014