Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants

Inclusion criteria

• Term (no less than 37 weeks, 0 days and less than 42 weeks, 0 days), singleton infant.
• Birth weight of greater than or equal to 2500 grams.
• Designated healthy by a physician.
• Less than or equal to 14 days of age at enrollment.
• If formula fed, exclusively consuming and tolerating a cow's milk infant formula at enrollment and have a parent who agrees to feed the study formula as a sole source of nutrition for a minimum of 16 weeks.
• If human milk fed, predominantly consuming and tolerating human milk and have a mother/parent who plans to predominantly feed human milk as sole source of nutrition for a minimum of 16 weeks.
• Weight for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
• Length for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
• Head circumference for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
• Weight for length greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
• Not currently receiving and have a parent/guardian who does not plan to give pre- and/or pro-biotics for the full duration of the study.
• Not currently participating in an interventional clinical trial and have a parent(s) or legal guardian(s) who agree not to enroll the infant in an interventional clinical trial while participating in this trial.
• Have parent(s) or legal guardian(s) who are capable of completing the written records, questionnaires, and study procedures required by the protocol.
• Have a parent(s) or legal guardian(s) who have read and voluntarily signed the Institutional Review Board Informed Consent prior to study participation.

Exclusion criteria

• Evidence of any anatomic or physiologic condition that would interfere with normal growth, development, or feeding.
• Infants required to take medications know to influence growth and development.
• Maternal history with known adverse effects on the fetus and/or the newborn infants.
• Family history of cow milk protein allergy or soy intolerance/allergy.
• Infants receiving any amount supplemental human milk with infant formula or visa-versa at time of enrollment.
• Infants from a multiple birth.