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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

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.

Condition or disease Intervention/treatment
Cognitive Ability, General Dietary Supplement: Enriched Protein Fractions Dietary Supplement: Protein Fraction

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Study Type : Observational
Estimated Enrollment : 116 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


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




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

Secondary Outcome Measures :
  1. Dimensional Change Card Sort (DCCS) [ Time Frame: At 5.5 years of age ]
  2. Stroop Task [ Time Frame: At 5.5 years of age ]
  3. Functional Near Infrared Spectroscopy (fNIRS) [ Time Frame: At 5.5 years of age ]
  4. Child Behavior Checklist (CBCL) [ Time Frame: At 5.5 years of age ]
  5. Body weight [ Time Frame: At 5.5 years of age ]
  6. Body height [ Time Frame: At 5.5 year of age ]
  7. Health history outcomes [ Time Frame: At 5.5 years of age ]


Information from the National Library of Medicine

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Ages Eligible for Study:   64 Months to 68 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Participants who previously consumed study formula through one year of age in MJN Project 6027.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04442477


Contacts
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Contact: Ashlee Kirchoff 812-479-7997 ashlee.kirchoff@rb.com

Locations
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China
Fuyang Fifth People's Hospital Recruiting
Anhui, China
Contact: Weirong Hu         
Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
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Principal Investigator: Fei Li Shanghai Children's Medical Center
Study Director: Steven Wu, M.D. Mead Johnson/RB
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Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT04442477    
Other Study ID Numbers: 6027-2
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No