To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a commercial infant formula and human breast milk.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
424
Alabama Clinical Therapeutics, LLC
Weight
Weight gain per day
Time frame: Study Day (SD) 14 - 119
Stool Characteristics
Stool consistency and number per day
Time frame: Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
Feeding Tolerance
% of feedings with spit up associated with feeding
Time frame: Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
Length
Length and interval length gain per day
Time frame: Study Day (SD) 1, 14, 28, 42, 84 and 119 visits
Head Circumference
Head circumference (HC) and interval HC gain per day
Time frame: Study Day (SD) 1, 14, 28, 42, 84 and 119 visits
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Feeding ad libitum
Birmingham, Alabama, United States
Alabama Clinical Therapeutics
Dothan, Alabama, United States
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Atlantic Clinical Research Collaborative
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Lake Mary Pediatrics
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SCORE Physician Alliance, LLC
St. Petersburg, Florida, United States
USF, College of Medicine, Dept of Pediatrics
Tampa, Florida, United States
Southeast Regional Research Group (SERRG)
Columbus, Georgia, United States
...and 15 more locations