Status:
COMPLETED
Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term
Lead Sponsor:
Perrigo Nutritionals
Conditions:
Growth
Eligibility:
All Genders
1-21 years
Phase:
NA
Brief Summary
The purpose of this study is to assess growth in infants who are fed an extensively hydrolyzed formula.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00936637
Start Date
July 1 2007
End Date
December 1 2008
Last Update
July 10 2009
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22908