Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions

Cognitive Ability, General Clinical Trial

Official title:

Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04442477
• Other study ID #: 6027-2
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cognitive Ability, General

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