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