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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enriched Protein Fractions | Dietary Supplement | Enriched protein fractions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wechsler Preschool & Primary Scale of Intelligenceâ„¢ (Fourth Edition; WPPSIâ„¢-IV) | At 5.5 years of age |
| Measure | Description | Time Frame |
|---|---|---|
| Dimensional Change Card Sort (DCCS) | At 5.5 years of age | |
| Stroop Task | At 5.5 years of age | |
| Functional Near Infrared Spectroscopy (fNIRS) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who previously consumed study formula through one year of age in MJN Project 6027.
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| Name | Affiliation | Role |
|---|---|---|
| Fei Li | Shanghai Children's Medical Center | Principal Investigator |
| Steven Wu, M.D. | Mead Johnson/RB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuyang Fifth People's Hospital | Anhui | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37192722 | Derived | 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. |
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| Protein Fraction | Dietary Supplement | Protein fractions |
|
| At 5.5 years of age |
| Child Behavior Checklist (CBCL) | At 5.5 years of age |
| Body weight | At 5.5 years of age |
| Body height | At 5.5 year of age |
| Health history outcomes | At 5.5 years of age |