NCT02626143
Completed
N/A
Effect of Feeding Mode on Infant Growth and Cognitive Function
Mead Johnson Nutrition1 site in 1 country582 target enrollmentFebruary 2016
ConditionsInfant Nutrition
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Infant Nutrition
- Sponsor
- Mead Johnson Nutrition
- Enrollment
- 582
- Locations
- 1
- Primary Endpoint
- Head circumference
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Head circumference
Time Frame: 24 months
Auditory Event-related Potential
Time Frame: 24 months
Body length
Time Frame: 24 months
Body weight
Time Frame: 24 months
Secondary Outcomes
- Medically confirmed adverse events(24 months)
- Body Composition: Deuterium Dilution(12 and 24 months)
- Language development: Rule Inference(10 months)
- Language development: Word Discovery(10 months)
- Dietary Intake(24 months)
- Blood sample: Metabolic markers(24 months)
- Blood sample: Micronutrient status(24 months)
- Language development: Native3 Phoneme Repertory(12 months)
- Body Composition: Air Displacement Plethysmography(6 months)
- Bayley Scales of Infant and Toddler Development(12 months)
- Sleep measures (Amount of time awake & asleep in a 7-day period)(24 months)
- Language development: MacArthur Communicative Development Inventory(24 months)
Study Sites (1)
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