Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions
Completed
- Conditions
- Cognitive Ability, General
- Registration Number
- NCT04442477
- Lead Sponsor
- Mead Johnson Nutrition
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wechsler Preschool & Primary Scale of Intelligence™ (Fourth Edition; WPPSI™-IV) At 5.5 years of age
- Secondary Outcome Measures
Name Time Method 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 Child Behavior Checklist (CBCL) At 5.5 years of age Health history outcomes At 5.5 years of age Stroop Task At 5.5 years of age
Trial Locations
- Locations (1)
Fuyang Fifth People's Hospital
🇨🇳Anhui, China
Fuyang Fifth People's Hospital🇨🇳Anhui, China