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Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00936637
First Posted: July 10, 2009
Last Update Posted: July 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Perrigo Nutritionals
  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
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.

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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: July 8, 2009
First Posted: July 10, 2009
Last Update Posted: July 10, 2009
Last Verified: July 2009