Growth and Tolerance of Young Infants Fed Infant Formula
- Conditions
- Growth and Tolerance
- Interventions
- Other: Experimental Infant FormulaOther: Control Infant Formula
- Registration Number
- NCT04105686
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
This is a randomized, multicenter, controlled, double-blind, parallel study to evaluate growth and tolerance of healthy term infants fed milk-based infant formulas.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 366
- Participant is judged to be in good health as determined from participant's medical history.
- 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) who elect to formula-feed the participant, confirm their intention to feed their infant the study product as the sole source of feeding during the study.
- Parent(s) who elect to feed the participant human milk, confirm their intention to exclusively feed human milk as the sole source of feeding during the study.
- Parent(s) of formula-fed infants confirm their intention not to administer vitamin or mineral supplements, (except for vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study.
- Parent(s) of human milk-fed infants confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study (vitamins and minerals are acceptable).
- Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or applicable privacy regulation) authorization prior to any participation in the study.
- 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 (including over the counter), prebiotics, probiotics, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance.
- Participant participates in another study that has not been approved as a concomitant study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Infant Formula Experimental Infant Formula Milk-based study product with oligosaccharides Control Infant Formula Control Infant Formula Milk-based study product
- Primary Outcome Measures
Name Time Method Weight Day of life 14 to Day of life 119 Weight gain per day
- Secondary Outcome Measures
Name Time Method Stool Characteristics Study Day 1 to Day of life 119 Parent completed diary
Head Circumference (HC) Day of life 14 to Day of life 119 HC gain per day
Length Day of life 14 to Day of life 119 Length gain per day
Formula Tolerance Study Day 1 to Day of life 119 Parent completed diary
Trial Locations
- Locations (32)
Springs Medical Research
🇺🇸Owensboro, Kentucky, United States
Central Research Associates
🇺🇸Birmingham, Alabama, United States
Visions Clinical Research
🇺🇸Tucson, Arizona, United States
Children's Research, LLC
🇺🇸Lake Mary, Florida, United States
Tekton Research
🇺🇸Chamblee, Georgia, United States
Meridian Clinical Research 3080
🇺🇸Baton Rouge, Louisiana, United States
University Clinical Research-Deland, LLC dba Avail Clinical Research- West Volusia Pediatrics
🇺🇸DeLand, Florida, United States
PAS Research, LLC
🇺🇸Tampa, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Asclepes Research Centers
🇺🇸Spring Hill, Florida, United States
Saltzer Health
🇺🇸Nampa, Idaho, United States
Midsouth Center for Clinical Research
🇺🇸Memphis, Tennessee, United States
Medical Research Center of Memphis
🇺🇸Memphis, Tennessee, United States
ClinOhio Research Services
🇺🇸Columbus, Ohio, United States
PriMed Clinical Research
🇺🇸Dayton, Ohio, United States
Gadolin Research, LLC
🇺🇸Beaumont, Texas, United States
Ohio Pediatric Research Association
🇺🇸Dayton, Ohio, United States
Score Physician Alliance, LLC
🇺🇸Saint Petersburg, Florida, United States
TOPAZ Clinical Research, Inc.
🇺🇸Apopka, Florida, United States
Wake Research - Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Aspen Clinical Research LLC
🇺🇸Orem, Utah, United States
Southeastern Pediatric Associates
🇺🇸Dothan, Alabama, United States
Applied Research Center of Arkansas
🇺🇸Little Rock, Arkansas, United States
Deaconess Clinic, Inc.
🇺🇸Evansville, Indiana, United States
Meridan Clinical Research
🇺🇸Omaha, Nebraska, United States
Mercury Clincial Research, Inc.
🇺🇸Houston, Texas, United States
Institute of Clinical Research, LLC
🇺🇸Mentor, Ohio, United States
Women's Hospital at Renaissance - Doctors Hospital at Renaissance
🇺🇸Edinburg, Texas, United States
MultiCare Institute for Research and Innovation
🇺🇸Tacoma, Washington, United States
Pediatric & Adult Research Center
🇺🇸Orlando, Florida, United States
The Cleveland Pediatric Research Center, LLC
🇺🇸Middleburg Heights, Ohio, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States