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

December 15, 2021 updated by: Mead Johnson Nutrition
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Anhui, China
        • Fuyang Fifth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants who previously consumed study formula through one year of age in MJN Project 6027.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental: Enriched Protein Fractions
This group was given Infant formula with enriched protein fractions
Dietary supplement: Enriched Protein Fractions
Enriched protein fractions
Active Comparator: Protein Fractions
This group was given Infant formula with protein fractions
Dietary supplement: Protein Fraction
Protein fractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Wechsler Preschool & Primary Scale of Intelligence™ (Fourth Edition; WPPSI™-IV)
Time Frame: At 5.5 years of age
At 5.5 years of age

Secondary Outcome Measures

Outcome Measure
Time Frame
Dimensional Change Card Sort (DCCS)
Time Frame: At 5.5 years of age
At 5.5 years of age
Stroop Task
Time Frame: At 5.5 years of age
At 5.5 years of age
Functional Near Infrared Spectroscopy (fNIRS)
Time Frame: At 5.5 years of age
At 5.5 years of age
Child Behavior Checklist (CBCL)
Time Frame: At 5.5 years of age
At 5.5 years of age
Body weight
Time Frame: At 5.5 years of age
At 5.5 years of age
Body height
Time Frame: At 5.5 year of age
At 5.5 year of age
Health history outcomes
Time Frame: At 5.5 years of age
At 5.5 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mead Johnson Nutrition

Investigators

  • Principal Investigator: Fei Li, Shanghai Children's Medical Center
  • Study Director: Steven Wu, M.D., Mead Johnson/RB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Actual)

May 27, 2021

Study Completion (Actual)

May 27, 2021

Study Registration Dates

First Submitted

June 18, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (Actual)

June 22, 2020

Study Record Updates

Last Update Posted (Actual)

December 16, 2021

Last Update Submitted That Met QC Criteria

December 15, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 6027-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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