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Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term

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ClinicalTrials.gov Identifier: NCT00936637
Recruitment Status : Completed
First Posted : July 10, 2009
Last Update Posted : July 10, 2009
Sponsor:
Information provided by:
Perrigo Nutritionals

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

Condition or disease Intervention/treatment Phase
Growth Other: Extensively hydrolyzed infant formula Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (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.
Study Start Date : July 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Extensively hydrolyzed infant formula Other: Extensively hydrolyzed infant formula



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


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Ages Eligible for Study:   up to 21 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936637


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

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
First Posted: July 10, 2009    Key Record Dates
Last Update Posted: July 10, 2009
Last Verified: July 2009