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Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term

This study has been completed.
Information provided by:
Perrigo Nutritionals Identifier:
First received: July 8, 2009
Last updated: July 9, 2009
Last verified: July 2009
The purpose of this study is to assess growth in infants who are fed an extensively hydrolyzed formula.

Condition Intervention
Other: Extensively hydrolyzed infant formula

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Care Provider)
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 Perrigo Nutritionals:

Primary Outcome Measures:
  • An extensively hydrolyzed formula is nutritionally adequate for normal growth of healthy full-term infants [ Time Frame: 16 weeks ]

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


Ages Eligible for Study:   up to 21 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00936637

United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Perrigo Nutritionals
Study Director: Cynthia M Barber, PhD Perrigo Nutritionals
  More Information

Responsible Party: Cynthia Barber, PhD; Vice President of Regulatory, Medical and Clinical Affairs, PBM Products Identifier: NCT00936637     History of Changes
Other Study ID Numbers: UVA Growth Study
Study First Received: July 8, 2009
Last Updated: July 9, 2009 processed this record on April 27, 2017