- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00936637
Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term
July 9, 2009 updated by: Perrigo Nutritionals
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.
The purpose of this study is to assess growth in infants who are fed an extensively hydrolyzed formula.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- University of Virginia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 3 weeks (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Extensively hydrolyzed infant formula
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
An extensively hydrolyzed formula is nutritionally adequate for normal growth of healthy full-term infants
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Cynthia M Barber, PhD, Perrigo Nutritionals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
July 8, 2009
First Submitted That Met QC Criteria
July 9, 2009
First Posted (Estimate)
July 10, 2009
Study Record Updates
Last Update Posted (Estimate)
July 10, 2009
Last Update Submitted That Met QC Criteria
July 9, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- UVA Growth Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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