NCT01380886
Completed
Phase 3
Growth and Tolerance of Young Infants Fed Infant Formulas
ConditionsInfant Newborn
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Infant Newborn
- Sponsor
- Abbott Nutrition
- Enrollment
- 209
- Locations
- 12
- Primary Endpoint
- Weight gain
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
This is a randomized, multi-center, double blind, parallel study to compare growth and tolerance of healthy term infants fed either control or experimental infant formula.
Investigators
Eligibility Criteria
Inclusion Criteria
- •healthy infant
- •full term
- •birth weight \> 2490 g
- •0 to 8 days of age
- •parent/physician agree to not use medications affecting tolerance/growth
- •parent agrees to sole source feeding of study formula
- •parent agrees to not use vitamin/mineral supplements
- •parent has signed consent/HIPAA authorization
Exclusion Criteria
- •any maternal, fetal, or infant history affecting growth and tolerance
- •participation in any other study not preapproved by Abbott
Outcomes
Primary Outcomes
Weight gain
Time Frame: 119 days
Secondary Outcomes
- gastrointestinal tolerance(119 days)
- Anthropometric variables(119 days)
Study Sites (12)
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