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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04442477
Enrollment
116
Registered
2020-06-22
Start date
2020-06-15
Completion date
2021-05-27
Last updated
2021-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Ability, General

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.

Interventions

DIETARY_SUPPLEMENTEnriched Protein Fractions

Enriched protein fractions

DIETARY_SUPPLEMENTProtein Fraction

Protein fractions

Sponsors

Mead Johnson Nutrition
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
64 Months to 68 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Wechsler Preschool & Primary Scale of Intelligence™ (Fourth Edition; WPPSI™-IV)At 5.5 years of age

Secondary

MeasureTime frame
Stroop TaskAt 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
Dimensional Change Card Sort (DCCS)At 5.5 years of age
Body heightAt 5.5 year of age
Health history outcomesAt 5.5 years of age
Body weightAt 5.5 years of age

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026