Sponsor study identifier
observational
116
1 country
1
Study Start
June 15, 2020
Actual (reported)Primary Completion
May 27, 2021
Actual (reported)Study Completion
May 27, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 27, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 15, 2020
Actual (reported)June 18, 2020
Actual (reported)June 22, 2020
Actual (reported)May 27, 2021
Actual (reported)May 27, 2021
Actual (reported)Wechsler Preschool & Primary Scale of Intelligence™ (Fourth Edition; WPPSI™-IV)
At 5.5 years of age
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
This group was given Infant formula with enriched protein fractions
This group was given Infant formula with protein fractions
Enriched protein fractions
Protein fractions
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Participants who previously consumed study formula through one year of age in MJN Project 6027.
Fuyang Fifth People's Hospital
Anhui, China
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.
Fei Li
Shanghai Children's Medical Center
Steven Wu, M.D.
Mead Johnson/RB
116 participants (actual enrollment reported by the registry).
First Submitted
June 18, 2020
First Posted
June 22, 2020
Study Start
June 15, 2020
Actual (reported)Cybercycling for Cognitive Health
Contact the study team to confirm eligibility.
Primary Completion
May 27, 2021
Actual (reported)Study Completion
May 27, 2021
Actual (reported)Last Updated
December 16, 2021
Record last verified: 2021-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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