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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
NameTimeMethod
Wechsler Preschool & Primary Scale of Intelligence™ (Fourth Edition; WPPSI™-IV)At 5.5 years of age
Secondary Outcome Measures
NameTimeMethod
Body weightAt 5.5 years of age
Body heightAt 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 outcomesAt 5.5 years of age
Stroop TaskAt 5.5 years of age

Trial Locations

Locations (1)

Fuyang Fifth People's Hospital

🇨🇳

Anhui, China

Fuyang Fifth People's Hospital
🇨🇳Anhui, China

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