Growth and Tolerance of Infants Fed Milk-Based Infant Formula
- Conditions
- Gastro-Intestinal Tolerance
- Interventions
- Other: Reference GroupOther: Control Infant FormulaOther: Experimental Infant Formula
- Registration Number
- NCT03967132
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 189
- Good health as determined from participant's medical history
- Singleton from a full-term birth with a gestational age of 37-42 weeks
- Birth weight was > 2490 g (~5 lbs. 8 oz.)
- If parent(s) of the participant elect to formula-feed the participant, parent(s) confirm the participant has not been given human milk since being discharged from the hospital following birth, and confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1-Visit 7, unless instructed otherwise by their healthcare professional.
- If parent(s) of the participant elect to feed the infant human milk, they confirm the infant has not received any formula prior to enrollment, and confirm their intention to exclusively feed human milk from birth, and as the sole source of feeding from Study Visit 1-Visit 7.
- Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.
- Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other 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 (OTC), such as Mylicon® for gas), prebiotics, probiotics, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance.
- Participant participates in another study that has not been approved as a concomitant study by AN.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reference Group Reference Group Human-milk fed Control Infant Formula Control Infant Formula Milk-based infant formula Experimental Infant Formula Experimental Infant Formula Milk-based Infant Formula with oligosaccharides
- Primary Outcome Measures
Name Time Method Weight Day of life 14 - 119 Weight gain per day
- Secondary Outcome Measures
Name Time Method Length Study Day 1 to Day of life 119 Length gain per day
Head Circumference (HC) Study Day 1 to Day of life 119 HC gain per day
Stool Characteristics Study Day 1 to Day of life 119 Parent completed diary
Illness Incidence Study Day 1 to Day of life 119 Parent reported incidence of illness
Formula Tolerance Study Day 1 to Day of life 119 Parent completed diary
Trial Locations
- Locations (19)
University Clinical Research-Deland, LLC a/b/a Accel Clinical Research
🇺🇸Orlando, Florida, United States
Institute of Clinical Research, LLC
🇺🇸Mentor, Ohio, United States
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
The Cleveland Pediatric Research Center, LLC
🇺🇸Middleburg Heights, Ohio, United States
Watching Over Mothers & Babies
🇺🇸Tucson, Arizona, United States
Phoenix Medical Research LLC
🇺🇸Miami, Florida, United States
Ventavia Research Group, LLC
🇺🇸Fort Worth, Texas, United States
Plano Pediatrics - ACRC Trials
🇺🇸Plano, Texas, United States
Norwich Pediatric Group, P.C.
🇺🇸Norwich, Connecticut, United States
Pediatric Medical Associates
🇺🇸Sacramento, California, United States
Deaconess Clinic, Inc.
🇺🇸Evansville, Indiana, United States
Kagan Pediatrics - HD Research Corporation
🇺🇸Pearland, Texas, United States
ARC Clinical Research at Wilson Parke
🇺🇸Austin, Texas, United States
Michael W. Simon, M.D., PSC
🇺🇸Nicholasville, Kentucky, United States
Springs Medical Research
🇺🇸Owensboro, Kentucky, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Midsouth Center for Clinical Research
🇺🇸Memphis, Tennessee, United States
Ventavia Research Group
🇺🇸Houston, Texas, United States
Ventavia Research Group, LLC 3078
🇺🇸Keller, Texas, United States