Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions
1 other identifier
observational
116
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2020
CompletedFirst Submitted
Initial submission to the registry
June 18, 2020
CompletedFirst Posted
Study publicly available on registry
June 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2021
CompletedDecember 16, 2021
December 1, 2021
12 months
June 18, 2020
December 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Wechsler Preschool & Primary Scale of Intelligence™ (Fourth Edition; WPPSI™-IV)
At 5.5 years of age
Secondary Outcomes (7)
Dimensional Change Card Sort (DCCS)
At 5.5 years of age
Stroop Task
At 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
Body weight
At 5.5 years of age
- +2 more secondary outcomes
Study Arms (2)
Experimental: Enriched Protein Fractions
This group was given Infant formula with enriched protein fractions
Active Comparator: Protein Fractions
This group was given Infant formula with protein fractions
Interventions
Enriched protein fractions
Eligibility Criteria
Participants who previously consumed study formula through one year of age in MJN Project 6027.
You may qualify if:
- Participant who previously consumed study formula through one year of age in MJN Project 6027
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuyang Fifth People's Hospital
Anhui, China
Related Publications (1)
Colombo J, Harris CL, Wampler JL, Zhuang W, Shaddy DJ, Liu BY, Wu SS. Improved Neurodevelopmental Outcomes at 5.5 Years of Age in Children Who Received Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula Through 12 Months: A Randomized Controlled Trial. J Pediatr. 2023 Oct;261:113483. doi: 10.1016/j.jpeds.2023.113483. Epub 2023 May 14.
PMID: 37192722DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Fei Li
Shanghai Children's Medical Center
- STUDY DIRECTOR
Steven Wu, M.D.
Mead Johnson/RB
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2020
First Posted
June 22, 2020
Study Start
June 15, 2020
Primary Completion
May 27, 2021
Study Completion
May 27, 2021
Last Updated
December 16, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share