Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions
NCT ID: NCT04442477
Last Updated: 2021-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
116 participants
OBSERVATIONAL
2020-06-15
2021-05-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Experimental: Enriched Protein Fractions
This group was given Infant formula with enriched protein fractions
Enriched Protein Fractions
Enriched protein fractions
Active Comparator: Protein Fractions
This group was given Infant formula with protein fractions
Protein Fraction
Protein fractions
Interventions
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Enriched Protein Fractions
Enriched protein fractions
Protein Fraction
Protein fractions
Eligibility Criteria
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Inclusion Criteria
* 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
64 Months
68 Months
ALL
Yes
Sponsors
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Mead Johnson Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Fei Li
Role: PRINCIPAL_INVESTIGATOR
Shanghai Children's Medical Center
Steven Wu, M.D.
Role: STUDY_DIRECTOR
Mead Johnson/RB
Locations
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Fuyang Fifth People's Hospital
Anhui, , China
Countries
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References
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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.
Other Identifiers
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6027-2
Identifier Type: -
Identifier Source: org_study_id