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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04442477
Other study ID # 6027-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 15, 2020
Est. completion date May 27, 2021

Study information

Verified date December 2021
Source Mead Johnson Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date May 27, 2021
Est. primary completion date May 27, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 64 Months to 68 Months
Eligibility 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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Enriched Protein Fractions
Enriched protein fractions
Protein Fraction
Protein fractions

Locations

Country Name City State
China Fuyang Fifth People's Hospital Anhui

Sponsors (1)

Lead Sponsor Collaborator
Mead Johnson Nutrition

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wechsler Preschool & Primary Scale of Intelligence™ (Fourth Edition; WPPSI™-IV) At 5.5 years of age
Secondary Dimensional Change Card Sort (DCCS) At 5.5 years of age
Secondary Stroop Task At 5.5 years of age
Secondary Functional Near Infrared Spectroscopy (fNIRS) At 5.5 years of age
Secondary Child Behavior Checklist (CBCL) At 5.5 years of age
Secondary Body weight At 5.5 years of age
Secondary Body height At 5.5 year of age
Secondary Health history outcomes At 5.5 years of age
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