Growth and Tolerance of Cow Milk-Based Infant Formulas
- Conditions
- Body Weight
- Registration Number
- NCT01122654
- Lead Sponsor
- Mead Johnson Nutrition
- Brief Summary
This clinical trial will assess growth, tolerance and adverse events of cow milk-based infant formulas in healthy, term infants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 405
- Singleton, 12-16 days of age at randomization
- Term infant with birth weight of minimum of 2500 g
- Solely formula fed
- Signed Informed Consent and Protected Health Information
- History of underlying metabolic or chronic disease or immunocompromised
- Acute infection
- Feeding difficulties or formula intolerance
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Body weight measured on calibrated infant scale at each study visit
- Secondary Outcome Measures
Name Time Method Twenty-four hour recall of infant formula intake at each study visit Medically-confirmed adverse events collected throughout the study period Twenty-four hour recall of stool characteristics (number and consistency) and tolerance at each study visit Parental Product Assessment Questionnaire completed at Study Visit 2 Assessment of physical properties of product and infant's reaction during consumption.
Body Length and Head Circumference measured at each study visit
Trial Locations
- Locations (24)
Birmingham Pediatric Associates
🇺🇸Birmingham, Alabama, United States
Southeastern Pediatric Associates
🇺🇸Dothan, Alabama, United States
Arkansas Pediatric Clinic
🇺🇸Little Rock, Arkansas, United States
Southwestern Medical Clinic, PC
🇺🇸Niles, Michigan, United States
Norwich Pediatric Group, PC
🇺🇸Norwich, Connecticut, United States
Central Arkansas Pediatric Clinic
🇺🇸Benton, Arkansas, United States
Pediatrics East - Alabama Clinical Therapeutics
🇺🇸Pinson, Alabama, United States
Children's Medical Association
🇺🇸Plantation, Florida, United States
PTCU/Children & Youth Project
🇺🇸Louisville, Kentucky, United States
Deaconess Clinic Gateway
🇺🇸Newburgh, Indiana, United States
North Georgia Clinical Research Center/White's Pediatrics
🇺🇸Dalton, Georgia, United States
Owensboro Pediatrics
🇺🇸Owensboro, Kentucky, United States
The Center for Human Nutrition
🇺🇸Omaha, Nebraska, United States
Innovis Health South University
🇺🇸Fargo, North Dakota, United States
Cary Pediatric Center, PA
🇺🇸Cary, North Carolina, United States
Primary Physicians Research, Inc
🇺🇸Pittsburgh, Pennsylvania, United States
The Jackson Clinic - North Jackson
🇺🇸Jackson, Tennessee, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Austin Diagnostic Clinic
🇺🇸Austin, Texas, United States
Red Lion Pediatrics
🇺🇸Philadelphia, Pennsylvania, United States
Altamonte Pediatric Associates
🇺🇸Lake Mary, Florida, United States
Southwestern Medical Clinic P.C.
🇺🇸Stevensville, Michigan, United States
Woburn Pediatric Associates
🇺🇸Woburn, Massachusetts, United States
Alpha Clinical Research
🇺🇸Clarksville, Tennessee, United States