Nutritive Effects of Cow's Milk-Based Formulas Through 18 Months of Age

Inclusion Criteria:

• Singleton birth
• Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age)
• Birth weight of 2500 g (5 lbs 8 oz) or more
• Parent(s) or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
• Signed informed consent obtained for infant's participation in the study
• Signed authorization obtained to use and/or disclose Protected Health Information for infant from birth through 18 months of age

Infants receiving formula:

• 3 to 60 days of age at randomization, inclusive (day of birth is considered day 0)
• Exclusively receiving infant formula for at least 72 hours prior to randomization
• Parent(s) or legal guardian has full intention to exclusively feed study formula during the study period

Infants receiving human milk:

• 150-180 days of age at registration, inclusive (day of birth is considered day 0)
• Mother has intention to predominately provide mother's own breast milk through at least 10 months of age

Exclusion Criteria:

• Contraindication to magnetic resonance imaging (MRI)
• First degree relative with known autism, intellectual disability, schizophrenia, or bipolar disorder or an inherited disorder of myelination
• Major pre- and/or perinatal issues (such as maternal pre-eclampsia, placental abruption, maternal alcohol or illicit drug use during pregnancy)
• Major delivery complications (such as neonatal hypoxia or neonatal illness requiring a greater than 2-day NICU stay)
• Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as combined immunodeficiencies, DiGeorge syndrome, Wiskott-Aldrich syndrome, severe congenital neutropenia and secondary immunodeficiencies linked to HIV infection, Down syndrome or others)
• 5 minute APGAR < 7
• Infant was born large for gestational age (LGA) (as confirmed by the hospital birth records) from mother who was diabetic at childbirth
• Infant has been identified with inadequate weight gain or failure to thrive by a health care professional (HCP)
• History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant
• Parent(s) or legal guardian unable to speak English at a level to provide informed consent

Infants receiving formula:

• Evidence of feeding difficulties or history of formula intolerance, such as vomiting or poor intake at time of randomization

Infants receiving human milk:

• Use of infant formula and/or donor milk more than three times per week prior to registration