Growth and Tolerance of Hypoallergenic Formulas
- Conditions
- Growth of Term Infants
- Interventions
- Other: Infant formula
- Registration Number
- NCT01354366
- Lead Sponsor
- Mead Johnson Nutrition
- Brief Summary
This clinical trial will evaluate two investigational hypoallergenic infant formulas with a differing protein content to determine if they provide normal growth and are well tolerated by term infants as compared to a marketed hypoallergenic formula.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 511
- Singleton, 12-16 days of age at randomization
- Term infant with birth weight of a minimum of 2500 grams
- Solely formula fed
- Signed Informed Consent and Protected Health Information
- History of underlying metabolic or chronic disease or immunocompromised
- Feeding difficulties or formula intolerance
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control Infant formula Marketed hypoallergenic infant formula containing a probiotic Experimental 1 Infant formula An investigational hypoallergenic infant formula with a different protein content, containing the same probiotic as the control Experimental 2 Infant formula An investigational hypoallergenic infant formula with a different protein content, without a probiotic
- Primary Outcome Measures
Name Time Method Body weight measured at each study visit 3.5 months
- Secondary Outcome Measures
Name Time Method Recall of infant formula intake at each study visit 3.5 months Body Length and Head Circumference measured at each study visit 3.5 months Recall of stool characteristics and tolerance at each study visit 3.5 months Medically-confirmed adverse events collected throughout the study period 3.5 months Parental Product Assessment Questionnaire completed at Study Visit 2 once
Trial Locations
- Locations (24)
Capital Pediatrics & Adolescent Center
🇺🇸Raleigh, North Carolina, United States
Red Lion Pediatrics
🇺🇸Philadelphia, Pennsylvania, United States
Southeastern Pediatric Associates
🇺🇸Dothan, Alabama, United States
Altamonte Pediatric Associates
🇺🇸Lake Mary, Florida, United States
Deaconess Clinic
🇺🇸Newburgh, Indiana, United States
Central Arkansas Pediatric Clinic
🇺🇸Benton, Arkansas, United States
Children's Medical Association
🇺🇸Plantation, Florida, United States
North Georgia Clinical Research Center/White's Pediatrics
🇺🇸Dalton, Georgia, United States
Gretchen Swanson Center for Nutrition
🇺🇸Omaha, Nebraska, United States
Woburn Pediatric Associates
🇺🇸Woburn, Massachusetts, United States
Pediatrics East - Alabama Clinical Therapeutics
🇺🇸Pinson, Alabama, United States
The Children's Clinic of Jonesboro
🇺🇸Jonesboro, Arkansas, United States
Owensboro Pediatrics
🇺🇸Owensboro, Kentucky, United States
Birmingham Pediatric Associates
🇺🇸Birmingham, Alabama, United States
Arkansas Pediatric Clinic
🇺🇸Little Rock, Arkansas, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Pediatric Associates of Fairfield, Inc
🇺🇸Fairfield, Ohio, United States
PTCU/Children and Youth Project
🇺🇸Louisville, Kentucky, United States
Pediatric Associates of Mt. Carmel, Inc
🇺🇸Cincinnati, Ohio, United States
The Jackson Clinic - North Jackson
🇺🇸Jackson, Tennessee, United States
Norwich Pediatric Group, P.C.
🇺🇸Norwich, Connecticut, United States
Innovis Health South University
🇺🇸Fargo, North Dakota, United States
Austin Diagnostic Clinic
🇺🇸Austin, Texas, United States
Primary Physicians Research, Inc
🇺🇸Pittsburgh, Pennsylvania, United States