NCT02433600
Terminated
Not Applicable
The Effect of Feeding Infant Formula With Enriched Protein Fractions
Mead Johnson Nutrition1 site in 1 country2 target enrollmentAugust 2015
ConditionsDeclarative Memory
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Declarative Memory
- Sponsor
- Mead Johnson Nutrition
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Sequence Recall using 3-dimensional props
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
This study is intended to measure declarative or stored memory and behavior between infants who consume one of two infant formulas through approximately one year of age.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Singleton, 0-90 days of age at randomization
- •Term infant with birth weight of a minimum of 2500 grams
- •Receiving at least 75% of the recommended caloric intake from cow's milk-based infant formula
- •Parent or legally authorized representative attending study visits reads, understands, and speaks English
- •Signed Informed Consent and Protected Health Information authorization
Exclusion Criteria
- •History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
- •Feeding difficulties or formula intolerance
- •Infant born small for gestational age
- •Infant born from a mother who was diabetic at childbirth
- •History of seizures or neurological disorders or infant with known head/brain disease/injury
Outcomes
Primary Outcomes
Sequence Recall using 3-dimensional props
Time Frame: 365 days of age
Secondary Outcomes
- Electroencephalogram response to stimuli(180 days of age)
- Bayley Scales of Infant and Toddler Development, Third Edition(365 days of age)
- Achieved Head Circumference(52 weeks)
- Sequence Recall using 3-dimensional props(300 days of age)
- Infant Behavior Questionnaire Revised, Short(240 days of age)
- Achieved Length(52 weeks)
- Formula Intake(52 weeks)
- Medically-confirmed Adverse Events(52 weeks)
- MacArthur-Bates Communication Development Inventory(365 days of age)
- Achieved Weight(52 weeks)
Study Sites (1)
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