NCT04442477
Completed
N/A
Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions
Mead Johnson Nutrition1 site in 1 country116 target enrollmentJune 15, 2020
ConditionsCognitive Ability, General
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cognitive Ability, General
- Sponsor
- Mead Johnson Nutrition
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Wechsler Preschool & Primary Scale of Intelligence™ (Fourth Edition; WPPSI™-IV)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a follow-up study of a multi-center, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate neurodevelopment at 5.5 years of age and health outcomes through 5.5 years of age in participants who received one of two staged study formulas through one year of age.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant who previously consumed study formula through one year of age in MJN Project 6027
- •5.5 years of age (i.e. when child turns 5 years and 6 months old ± 2 months) at Visit 1
- •Signed informed consent obtained for child's participation in the study
Exclusion Criteria
- •No exclusion criteria
Outcomes
Primary Outcomes
Wechsler Preschool & Primary Scale of Intelligence™ (Fourth Edition; WPPSI™-IV)
Time Frame: At 5.5 years of age
Secondary Outcomes
- Body weight(At 5.5 years of age)
- Body height(At 5.5 year of age)
- Dimensional Change Card Sort (DCCS)(At 5.5 years of age)
- Functional Near Infrared Spectroscopy (fNIRS)(At 5.5 years of age)
- Health history outcomes(At 5.5 years of age)
- Child Behavior Checklist (CBCL)(At 5.5 years of age)
- Stroop Task(At 5.5 years of age)
Study Sites (1)
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