Infant Nutrition
Conditions
Brief summary
This study is intended to compare growth, nutritional status, and brain development in children fed an Investigational cow's milk based formula containing a nutrient-rich whey protein, a standard cow's milk based formula, or fed exclusively breast milk.
Interventions
OTHERInvestigational nutrient-rich whey protein formula
OTHERCow's milk based formula
Sponsors
Instituto de Nutricion y Tecnologia de los Alimentos (INTA)
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
0 Days to 120 Days
Healthy volunteers
Yes
Inclusion criteria
* Singleton, 0-120 days of age at study entry * Term infant with birth weight of 2500 to 4500 grams * Exclusively feed infant formula or exclusively feeding breast milk * Signed informed consent
Exclusion criteria
* History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised. * Feeding difficulties or formula intolerance * Receiving complementary feedings
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight | 24 months |
| Auditory Event-related Potential | 24 months |
| Body length | 24 months |
| Head circumference | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Dietary Intake | 24 months |
| Medically confirmed adverse events | 24 months |
| Body Composition: Air Displacement Plethysmography | 6 months |
| Body Composition: Deuterium Dilution | 12 and 24 months |
| Language development: Native3 Phoneme Repertory | 12 months |
| Blood sample: Metabolic markers | 24 months |
| Bayley Scales of Infant and Toddler Development | 12 months |
| Sleep measures (Amount of time awake & asleep in a 7-day period) | 24 months |
| Blood sample: Micronutrient status | 24 months |
| Language development: Word Discovery | 10 months |
| Language development: Rule Inference | 10 months |
| Language development: MacArthur Communicative Development Inventory | 24 months |
Countries
Chile
Outcome results
None listed