Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term
Not Applicable
Completed
- Conditions
- Growth
- Interventions
- Other: Extensively hydrolyzed infant formula
- Registration Number
- NCT00936637
- Lead Sponsor
- Perrigo Nutritionals
- Brief Summary
The purpose of this study is to assess growth in infants who are fed an extensively hydrolyzed formula.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Extensively hydrolyzed infant formula Extensively hydrolyzed infant formula -
- Primary Outcome Measures
Name Time Method An extensively hydrolyzed formula is nutritionally adequate for normal growth of healthy full-term infants 16 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Virginia
🇺🇸Charlottesville, Virginia, United States