Mead Johnson Nutrition
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 recei…
Inclusion Criteria: * 10 to 14 days of age at randomization, inclusive (day of birth is considered Day 0) * Singleton birth * Gestational age of 37 weeks + 0 days to 41 weeks + 6 days, inclusive * Birth weight of 2500 g to 4200 g, inclusive * Birth weight appropriate for gestational age (AGA, defined as birth weight-for-age between 10th and 90th percentile, inclusive) * Exclusively receiving infant formula for at least 24 hours prior to randomization * Parent(s) or legal guardian(s) have full intention to exclusively feed their infant study formula through 126 days of age * Signed informed co…
A commercially available extensively hydrolyzed casein formula
An extensively hydrolyzed casein formula