Declarative Memory Clinical Trial
Official title:
The Effect of Feeding Infant Formula With Enriched Protein Fractions
| Verified date | March 2016 |
| Source | Mead Johnson Nutrition |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 2 |
| Est. completion date | October 2015 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A to 90 Days |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
| Country | Name | City | State |
|---|---|---|---|
| United States | University or North Carolina Nutrition Research Instutite | Kannapolis | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Mead Johnson Nutrition | University of North Carolina, Chapel Hill |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Sequence Recall using 3-dimensional props | 365 days of age | No | |
| Secondary | Electroencephalogram response to stimuli | 180 days of age | No | |
| Secondary | Sequence Recall using 3-dimensional props | 300 days of age | No | |
| Secondary | Infant Behavior Questionnaire Revised, Short | 240 days of age | No | |
| Secondary | MacArthur-Bates Communication Development Inventory | 365 days of age | No | |
| Secondary | Bayley Scales of Infant and Toddler Development, Third Edition | 365 days of age | No | |
| Secondary | Achieved Weight | 52 weeks | No | |
| Secondary | Achieved Length | 52 weeks | No | |
| Secondary | Achieved Head Circumference | 52 weeks | No | |
| Secondary | Formula Intake | 52 weeks | No | |
| Secondary | Medically-confirmed Adverse Events | 52 weeks | No |