Growth and Tolerance of Infants Fed Infant Formulas
- Conditions
- Growth and Tolerance
- Interventions
- Other: Human MilkOther: Experimental Formula 2Other: Experimental Formula 1Other: Control Formula
- Registration Number
- NCT01808105
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a commercial infant formula and human breast milk.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 424
- Singleton from full term birth with a gestational age 37-42 weeks
- Birth weight > 2490 g (~5 lbs 8 oz)
- Between 0 and 5 days of age
- Smoke-free home (no smoking in the house dwelling), and mothers in the breast-fed group are prohibited from smoking during the study period
- Parent(s) of formula-fed infants have elected not to breastfeed and confirm that their infant has been exclusively formula-fed since birth and confirm their intention is to exclusively feed their infant study infant formula for the duration of the study,
- Parent(s) of human milk-fed infants have elected to breastfeed and confirm that their infant has been exclusively human milk-fed (not donor milk) since birth and confirm their intention is to continue to exclusively feed human milk with vitamin/mineral supplementation for the duration of the study
- No administration vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D, if recommended by a healthcare professional), solid foods or juices to infants from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional
- Adverse maternal, fetal or infant medical history that has potential effects on tolerance, growth, and/or development
- Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance may not be enrolled
- Treatment with antibiotics
- Mother intends to use a combination of breast and formula feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Human Milk Human Milk Reference group, breast feeding ad libitum Experimental Formula 2 Experimental Formula 2 Ready to feed infant formula with human milk oligosaccharides, feed ad libitum Experimental Formula 1 Experimental Formula 1 Ready to feed infant formula with human milk oligosaccharides, feed ad libitum Control Formula Control Formula Ready to feed infant formula, feed ad libitum
- Primary Outcome Measures
Name Time Method Weight Study Day (SD) 14 - 119 Weight gain per day
- Secondary Outcome Measures
Name Time Method Length Study Day (SD) 1, 14, 28, 42, 84 and 119 visits Length and interval length gain per day
Head Circumference Study Day (SD) 1, 14, 28, 42, 84 and 119 visits Head circumference (HC) and interval HC gain per day
Stool Characteristics Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits Stool consistency and number per day
Feeding Tolerance Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits % of feedings with spit up associated with feeding
Trial Locations
- Locations (25)
Women's Clinic of Lincoln, PC
🇺🇸Lincoln, Nebraska, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Alabama Clinical Therapeutics
🇺🇸Dothan, Alabama, United States
Alabama Clinical Therapeutics, LLC
🇺🇸Birmingham, Alabama, United States
W.O.M.B Watching Over Mothers and Babies
🇺🇸Tucson, Arizona, United States
Atlantic Clinical Research Collaborative
🇺🇸Boynton Beach, Florida, United States
SCORE Physician Alliance, LLC
🇺🇸St. Petersburg, Florida, United States
USF, College of Medicine, Dept of Pediatrics
🇺🇸Tampa, Florida, United States
Lake Mary Pediatrics
🇺🇸Orange City, Florida, United States
Norwich Pediatric Group, PC
🇺🇸Norwich, Connecticut, United States
PediaResearch, LLC
🇺🇸Evansville, Indiana, United States
Southeast Regional Research Group (SERRG)
🇺🇸Columbus, Georgia, United States
Northpoint Pediatrics, LLC
🇺🇸Indianapolis, Indiana, United States
Lafayette Clinical Research
🇺🇸Lafayette, Indiana, United States
Dayton Clinical Research
🇺🇸Dayton, Ohio, United States
Ohio Pediatric Research Association, Inc
🇺🇸Dayton, Ohio, United States
Institute of Clinical Research
🇺🇸Mayfield Heights, Ohio, United States
Clinical Trials of America
🇺🇸Eugene, Oregon, United States
Red Lion Pediatrics
🇺🇸Philadelphia, Pennsylvania, United States
Sanford Research
🇺🇸Sioux Falls, South Dakota, United States
Tanner Memorial Clinic
🇺🇸Layton, Utah, United States
Clinical Research Puerto Rico
🇵🇷Guayama, Puerto Rico
Ponce School of Medicine/ CAIMED Center
🇵🇷Ponce, Puerto Rico
Rockwood Clinic, PS
🇺🇸Spokane, Washington, United States
Clinical Research Advantage/Colorado Springs Health Partners
🇺🇸Colorado Springs, Colorado, United States