Growth
Conditions
Brief summary
The purpose of this study is to assess growth in infants who are fed an extensively hydrolyzed formula.
Interventions
OTHERExtensively hydrolyzed infant formula
Sponsors
Perrigo Nutritionals
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
1 Days to 21 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An extensively hydrolyzed formula is nutritionally adequate for normal growth of healthy full-term infants | 16 weeks |
Countries
United States
Outcome results
None listed