Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas
- Conditions
- Growth
- Interventions
- Other: Cow's milk-based infant formula with added nutrientsOther: Marketed cow's milk-based infant formula
- Registration Number
- NCT02860026
- Lead Sponsor
- Mead Johnson Nutrition
- Brief Summary
This clinical trial will compare the growth and tolerance of infants who consume an investigational cow's milk-based infant formula to those who consume a marketed cow's milk-based infant formula through approximately 4 months of age.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Singleton 10-14 days of age at randomization
- Term infant with birth weight of minimum of 2500 grams
- Solely formula fed
- Signed informed consent and protected health information
- History of underlying metabolic or chronic disease, anemia, or immune compromise
- Feeding difficulties or formula intolerance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Investigational Cow's milk-based infant formula with added nutrients Cow's milk-based infant formula with added nutrients Control Marketed cow's milk-based infant formula Marketed cow's milk-based infant formula
- Primary Outcome Measures
Name Time Method Rate of body weight gain from 14 to 120 days of age 3.5 months
- Secondary Outcome Measures
Name Time Method Medically confirmed adverse events collected throughout the study period Up to 3.5 months Recall of infant formula at each study visit Up to 3.5 months Body length measured at each study visit Up to 3.5 months Head circumference measured at each study visit Up to 3.5 months Recall of stool characteristics questionnaire measured at each study visit Up to 3.5 months Recall of gastrointestinal tolerance questionnaire at each study visit Up to 3.5 months
Trial Locations
- Locations (17)
Northwest Arkansas Pediatric Clinic
🇺🇸Fayetteville, Arkansas, United States
Norwich Pediatric Group, P.C.
🇺🇸Norwich, Connecticut, United States
Altamonte Pediatric Associates
🇺🇸Lake Mary, Florida, United States
Deaconess Clinical Research
🇺🇸Evansville, Indiana, United States
Pediatric Associates of Fairfield, Inc.
🇺🇸Fairfield, Ohio, United States
Ohio Pediatric Research Association
🇺🇸Dayton, Ohio, United States
The Jackson Clinic - North Jackson
🇺🇸Jackson, Tennessee, United States
UHMP Comprehensive Pediatrics
🇺🇸Westlake, Ohio, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
Birmingham Pediatric Associates
🇺🇸Birmingham, Alabama, United States
Southeastern Pediatric Associates
🇺🇸Dothan, Alabama, United States
The Children's Clinic of Jonesboro, P.A.
🇺🇸Jonesboro, Arkansas, United States
Kentucky Pediatrics/Adult Research
🇺🇸Bardstown, Kentucky, United States
Coastal Pediatric Research
🇺🇸Charleston, South Carolina, United States
Owensboro Pediatrics
🇺🇸Owensboro, Kentucky, United States
Pediatric Associates of Mt. Carmel, Inc.
🇺🇸Cincinnati, Ohio, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States