Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula
- Conditions
- Healthy Term Infants Solely Formula Fed
- Registration Number
- NCT00666120
- Lead Sponsor
- Mead Johnson Nutrition
- Brief Summary
To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator.
Hypothesize there will be no difference between formula groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 333
- Singleton birth
- Term infant at birth
- Birth weight of 2500 g (5 lbs 8 oz) or more
- 4 - 18 days of age at Study Visit 1
- History of underlying metabolic or chronic disease or congenital malformation
- Infant switched formulas more than one time between birth and Study Visit 1
- Known feeding problems at Study Visit 1
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator 60 days
- Secondary Outcome Measures
Name Time Method Infant temperament 60 days
Trial Locations
- Locations (18)
Harvey Pediatrics
🇺🇸Jonesboro, Arkansas, United States
Mercy Rogers Pediatric Clinic
🇺🇸Rogers, Arkansas, United States
Lovelace Scientific Resources
🇺🇸Santa Ana, California, United States
Tampa Bay Medical Research
🇺🇸Clearwater, Florida, United States
Children's Medical Association
🇺🇸Tamarac, Florida, United States
Children's Health Care
🇺🇸DeKalb, Illinois, United States
Welborn Clinic
🇺🇸Evansville, Indiana, United States
Fomon Infant Nutrition Unit
🇺🇸Iowa City, Iowa, United States
Heartland Research Associates
🇺🇸Wichita, Kansas, United States
Pediatrics Clinical Trials Unit
🇺🇸Louisville, Kentucky, United States
Scroll for more (8 remaining)Harvey Pediatrics🇺🇸Jonesboro, Arkansas, United States