Growth of Infants Fed an Elemental Medical Food
Phase 3
Completed
- Conditions
- Healthy Infants
- Registration Number
- NCT01699386
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
Effects on weight will be monitored in healthy infant subjects consuming assigned infant formulas.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 213
Inclusion Criteria
- Singleton, healthy infant
- Gestational age of 37 to 42 weeks
- Birth weight of 2500 grams or greater
- Age between birth and 9 days of age
- Parents agree to not administer mineral or vitamin supplements during the study period
- Parents agree to feed study formula exclusively for the duration of the study
Exclusion Criteria
- Maternal, fetal or perinatal history which may have adverse effects on growth
- Multiple birth
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Weight 14 days of age to 112 days of age weight gain during the study period
- Secondary Outcome Measures
Name Time Method Lab Measurement At 112 day visit serum albumin
Anthropometric Measurements 14 days of age to 112 days of age length, head circumference, and length gain
GI Tolerance At visits 14 and 28 daily stool number, stool consistency, formula intake
Trial Locations
- Locations (2)
T&W Research
🇺🇸Little Rock, Arkansas, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
T&W Research🇺🇸Little Rock, Arkansas, United States