Growth and Tolerance of Young Infants
- Conditions
- Growth
- Registration Number
- NCT03276884
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
To compare growth and tolerance of healthy term infants fed two amino acid-based infant formulas.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 267
- Subject is judged to be in good health.
- Singleton from a full-term birth with a gestational age of 37 - 42 weeks.
- Birth weight was ≥ 2490 g (~5 lbs. 8 oz.).
- Subject is between 0 and 8 days of age at enrollment.
- 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 vitamin or mineral supplements (with the exception of Vitamin D-containing supplements), solid foods or juices to their infant from enrollment through the duration of the study.
- Subject's parent(s) has voluntarily signed and dated an ICF prior to any participation in the study.
- An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Subject is taking and plans to continue medications, home remedies, herbal preparations, prebiotics, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance.
- Subject participates in another study that has not been approved as a concomitant study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Weight Gain Study Day 14 to Study Day 119 Infant scale
- Secondary Outcome Measures
Name Time Method GI tolerance Study Day 1 to Study Day 119 Parent completed questionnaires
Length Study Day 1 to Study Day 119 Length board
Head Circumference Study Day 1 to Study Day 119 Measure tape
Weight Study Day 1 to Study Day 119 Infant scale
Trial Locations
- Locations (22)
Alabama Clinical Therapeutics, LLC
🇺🇸Birmingham, Alabama, United States
Southeastern Pediatric Associates
🇺🇸Dothan, Alabama, United States
Watching Over Mothers and Babies
🇺🇸Tucson, Arizona, United States
The Children's Clinic of Jonesboro, P.A.
🇺🇸Jonesboro, Arkansas, United States
Norwich Pediatric Group, PC
🇺🇸Norwich, Connecticut, United States
Children's Research, LLC
🇺🇸Lake Mary, Florida, United States
Score Physician Alliance, LLC
🇺🇸Saint Petersburg, Florida, United States
Saltzer Medical Group
🇺🇸Nampa, Idaho, United States
Deaconess Clinic, Inc.
🇺🇸Evansville, Indiana, United States
Springs Medical Research
🇺🇸Owensboro, Kentucky, United States
Scroll for more (12 remaining)Alabama Clinical Therapeutics, LLC🇺🇸Birmingham, Alabama, United States