Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas
- Conditions
- Infant Development
- Interventions
- Other: Experimental Infant FormulaOther: Control Infant Formula
- Registration Number
- NCT04006236
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
This is a randomized, controlled, double-blind, multicenter parallel study to evaluate the growth, tolerance and compliance of healthy infants fed infant formulas with extensively hydrolyzed casein protein.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 245
- Participant is judged to be in good health
- Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks
- Participant's birth weight was > 2490 g (~5 lbs. 8 oz.)
- Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
- Parent(s) confirm their intention not to administer vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment throughout the duration of the study
- Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization
- An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Participant is taking and plans to continue taking medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
- Participant participates in another study that has not been approved as a concomitant study by AN.
- Participant has an allergy or intolerance to any ingredient in the study product
- Participant has been treated with antibiotics within 1 week prior to enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Infant Formula Experimental Infant Formula extensively hydrolyzed casein protein Control Infant Formula Control Infant Formula extensively hydrolyzed casein protein
- Primary Outcome Measures
Name Time Method Weight Day of Age (DOA) 14 to 119 Interval weight gain per day
- Secondary Outcome Measures
Name Time Method Length Study Day (SD) 1 to DOA 119 Interval length gain per day
Formula Intake Study Day (SD) 1 to DOA 119 Parent Completed Diary
Head Circumference Study Day (SD) 1 to DOA 119 Interval HC gain per day
Stool Characteristics Study Day (SD) 1 to DOA 119 Parent Completed Diary
Trial Locations
- Locations (14)
MedPharmics, LLC
🇺🇸Albuquerque, New Mexico, United States
Watching Over Mothers & Babies
🇺🇸Tucson, Arizona, United States
Paramount Research Solutions
🇺🇸College Park, Georgia, United States
Springs Medical Research
🇺🇸Owensboro, Kentucky, United States
Quality Clinical Research Inc
🇺🇸Omaha, Nebraska, United States
Ventavia Research Group, Llc
🇺🇸Fort Worth, Texas, United States
PMG Research of Peidmont Healthcare
🇺🇸Statesville, North Carolina, United States
Pediatric Associates of Fairfield, Inc.
🇺🇸Fairfield, Ohio, United States
Institute of Clinical Research, LLC
🇺🇸Mentor, Ohio, United States
The Cleveland Pediatric Research Center, LLC
🇺🇸Middleburg Heights, Ohio, United States
Children's Hospital
🇺🇸Sioux Falls, South Dakota, United States
Ventavia Research Group
🇺🇸Houston, Texas, United States
Midsouth Center for Clinical Research
🇺🇸Memphis, Tennessee, United States
Ventavia Research Group, LLC
🇺🇸Plano, Texas, United States