This is a research study to compare an investigational infant formula against a currently marketed infant formula. An investigational infant formula is one that has never been approved by the United States Food and Drug Administration (FDA). The purpose of this research study is to evaluate the growth and tolerance of infants who consume a new (not yet available to buy) extensively hydrolyzed cow milk protein infant formula compared to an extensively hydrolyzed cow milk protein infant formula that is currently available to buy. The study will also look at the growth of your baby, how many poops your baby has, what the poops are like (for example, soft or hard), how much study formula your baby drinks, how well your baby handles the study formula (such as spit-up, fussiness, gas, colic, or changes in sleep), and any health problems that might come up during the study.
The current study is designed to demonstrate that an investigational extensively hydrolyzed casein formula developed utilizing a new manufacturing process, is well-accepted, tolerated and supports typical growth similar to a control extensively hydrolyzed casein formula in term, healthy infants from approximately 14 to 126 days of age. This formula has been determined to have a high-quality protein similar to that of intact casein, as seen in the protein efficiency ratio (PER) study. Secondary objectives will include tolerance, intake and stool characteristics between infants assigned to receive the control or the investigational formula through approximately 126 days of age. Control and investigational formulas have the same nutritional composition per 100 kcal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
214
A commercially available extensively hydrolyzed casein formula
An extensively hydrolyzed casein formula
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Childrens Clinic of Jonesboro
Jonesboro, Arkansas, United States
SPRIM
Harbor Beach, Florida, United States
Symphony Research
Jacksonville, Florida, United States
Hope Research Network
Virginia Gardens, Florida, United States
Mid Valley Research Inc.
Moline, Illinois, United States
Springs Medical Research
Owensboro, Kentucky, United States
InnovoResearch
Wilmington, North Carolina, United States
AVIATI Healthcare & Clinical Research
Memphis, Tennessee, United States
...and 2 more locations
Rate of weight gain (g/day)
Time frame: up to 131 days of age
body length (cm)
Time frame: up to 131 days of age
Head Circumference (cm)
Time frame: up to 131 days of age
Body weight (g)
Time frame: up to 131 days of age
Growth z-scores
head circumference-for-age
Time frame: up to 131 days of age
Growth Z Scores
weight-for-age
Time frame: up to 131 days of age
Growth Z Scores
Length-for-age
Time frame: up to 131 days of age
Stool characteristics
Time frame: up to 131 days of age
Study formula intake
Time frame: up to 131 days of age
Tolerance
Time frame: up to 131 days of age
Medically confirmed adverse events
Time frame: up to 131 days of age
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