The Effects on Growth and Tolerance of a Routine Infant Formula Fed to Term Infants
- Conditions
- Growth of Term Infants
- Interventions
- Other: An investigational infant formula containing an alternate source of DHA
- Registration Number
- NCT02132663
- Lead Sponsor
- Mead Johnson Nutrition
- Brief Summary
This clinical trial will evaluate an investigational infant formula with an alternate source of DHA to determine if it provides normal growth and if it is well tolerated by term infants as compared to a marketed routine infant formula.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 315
- Singleton, 10-14 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
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Infant formula containing an alternate source of DHA An investigational infant formula containing an alternate source of DHA -
- Primary Outcome Measures
Name Time Method Body weight measured at each study visit 3.5 Months
- Secondary Outcome Measures
Name Time Method Medically-confirmed adverse events collected throughout the study period 3.5 months Head circumference measured at each study visit 3.5 months Body length measured at each study visit 3.5 months Recall of stool consistency measured at each study visit 3.5 months Recall of gastrointestinal tolerance measured at each study visit 3.5 months Blood Collection Once at 120 days of age Blood Collection from a subset of participants to measure levels of fatty acids such as docosahexaenoic acid (DHA) and arachidonic acid (ARA).
Recall of infant formula intake at each study visit 3.5 months
Trial Locations
- Locations (22)
Southeastern Pediatric Association
🇺🇸Dothan, Alabama, United States
Cary Pediatric Center
🇺🇸Cary, North Carolina, United States
Capital Pediatrics & Adolescent Center
🇺🇸Raleigh, North Carolina, United States
Birmingham Pediatric Associates
🇺🇸Birmingham, Alabama, United States
Pediatric Associates of Mt. Carmel, Inc
🇺🇸Cincinnati, Ohio, United States
Greenvale Pediatrics - Hoover
🇺🇸Birmingham, Alabama, United States
Northwest Arkansas Pediatric Clinic
🇺🇸Fayetteville, Arkansas, United States
Pediatrics East - Alabama Clinical Therapeutics
🇺🇸Pinson, Alabama, United States
The Children's Clinic of Jonesboro, P.A.
🇺🇸Jonesboro, Arkansas, United States
Norwich Pediatric Group, PC
🇺🇸Norwich, Connecticut, United States
Woburn Pediatic Associates
🇺🇸Woburn, Massachusetts, United States
Children's Research, LLC
🇺🇸Altamonte Springs, Florida, United States
Physician Care Clinical Research
🇺🇸Sarasota, Florida, United States
Owensboro Pediatrics
🇺🇸Owensboro, Kentucky, United States
Deaconess Clinical Research
🇺🇸Evansville, Indiana, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Pediatric Associates of Fairfield, Inc.
🇺🇸Fairfield, Ohio, United States
UHMP Comprehensive Pediatrics
🇺🇸Westlake, Ohio, United States
The Jackson Clinic - North Jackson
🇺🇸Jackson, Tennessee, United States
Austin Diagnostic Clinic
🇺🇸Austin, Texas, United States
Coastal Pediatric Research
🇺🇸Charleston, South Carolina, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States