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

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ClinicalTrials.gov Identifier: NCT04442477
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Mead Johnson Nutrition

Tracking Information
First Submitted Date June 18, 2020
First Posted Date June 22, 2020
Last Update Posted Date June 22, 2020
Actual Study Start Date June 15, 2020
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 18, 2020)
Wechsler Preschool & Primary Scale of Intelligence™ (Fourth Edition; WPPSI™-IV) [ Time Frame: At 5.5 years of age ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 18, 2020)
  • Dimensional Change Card Sort (DCCS) [ Time Frame: At 5.5 years of age ]
  • Stroop Task [ Time Frame: At 5.5 years of age ]
  • Functional Near Infrared Spectroscopy (fNIRS) [ Time Frame: At 5.5 years of age ]
  • Child Behavior Checklist (CBCL) [ Time Frame: At 5.5 years of age ]
  • Body weight [ Time Frame: At 5.5 years of age ]
  • Body height [ Time Frame: At 5.5 year of age ]
  • Health history outcomes [ Time Frame: At 5.5 years of age ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions
Official Title Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants who previously consumed study formula through one year of age in MJN Project 6027.
Condition Cognitive Ability, General
Intervention
  • Dietary Supplement: Enriched Protein Fractions
    Enriched protein fractions
  • Dietary Supplement: Protein Fraction
    Protein fractions
Study Groups/Cohorts
  • Experimental: Enriched Protein Fractions
    This group was given Infant formula with enriched protein fractions
    Intervention: Dietary Supplement: Enriched Protein Fractions
  • Active Comparator: Protein Fractions
    This group was given Infant formula with protein fractions
    Intervention: Dietary Supplement: Protein Fraction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 18, 2020)
116
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 64 Months to 68 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: Ashlee Kirchoff 812-479-7997 ashlee.kirchoff@rb.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04442477
Other Study ID Numbers 6027-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Mead Johnson Nutrition
Study Sponsor Mead Johnson Nutrition
Collaborators Not Provided
Investigators
Principal Investigator: Fei Li Shanghai Children's Medical Center
Study Director: Steven Wu, M.D. Mead Johnson/RB
PRS Account Mead Johnson Nutrition
Verification Date June 2020