Growth and Safety Study of an Infant Formula for Healthy Term Infants

Inclusion Criteria

• •Infants will be eligible to participate if they meet all of the following conditions. At birth the infant must be:
• •1. Healthy, term (early term/no less than 37 weeks, 0 days through late term/no greater than 41 weeks, 6 days), singleton infant
• •2. Have a birth weight of ≥ 2500 grams
• •At the time of the baseline/enrollment visit, infants must be:
• •3. Designated as healthy by a physician
• •4. ≤14 days post-natal age (Date of Birth = Day 0)
• •5. Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
• •6. Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
• •7. Head circumference for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
• •8. Weight for length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
• •9. Exclusively consuming and tolerating a cow's milk infant formula at time of enrollment; only infants whose parent(s) or legal guardian(s) have decided to feed infant formula as the sole soure of nutrition, will be approached for potential study enrollment
• •10. Have parent(s) or legal guardian(s) who agree to feed the study formula to the study subject as his/her sole source of nutrition for the duration of the study
• •11. Have parent(s) or legal guardian(s) who have read and voluntarily signed an Informed Consent form approved by the Institutional Review Board prior to any participation in the study.
• •1. Show evidence of anatomic and physiologic defects of the respiratory tract, or other congenital defects (as determined by the clinician);
• •2. Show evidence of chronic hepatic, gastrointestinal, renal, cardiac, pulmonary, or neurological diseases;
• •3. Have a maternal history with known adverse effects on the fetus and/or the newborn infant, such as diabetes (gestational diabetes is acceptable if infant's birth weight is \< 4300 g), active tuberculosis, perinatal infection, or substance abuse
• •4. Have a family history of cow's milk protein intolerance/allergy
• •5. Are an infant from a multiple birth (twin, triplet, etc.) -