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NCT00735423 Clinical Trial

Infant Diet Effects on Brain Function and Language Processing (fMRI)

Healthy Clinical Trial

Official title:
Effects of Neonatal Diet on Language, Neurocognitive Functions at Eight Years Old: fMRI, ERP and Standardized Behavioral Measures

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00735423
Other study ID # 77556
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 2008
Est. completion date June 2024

Study information
Verified date December 2023
Source Arkansas Children's Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to identify neurocognitive functions and language processing of 8-year-old children who were fed either breast milk, milk-based formula or soy-based formula during the first year of life.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 90 Months to 101 Months
Eligibility Inclusion Criteria: - Healthy 8-year-old children - Full term - Birth weight between the 5th - 95th weight-for-age - Use of Breast milk, milk-based formula or soy-based formula throughout first year of life - English as primary language - Right handed first visit - BMI between 5th - 95th percentile-for-age Exclusion Criteria: - Children with sleep disorders - Children who use certain medications that may interfere with study assessments - Illnesses or diseases or conditions that may interfere with study assessments

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• No intervention
IDE used for outcome measurement not intervention

Locations
Country Name City State
United States Arkansas Children's Nutrition Center Little Rock Arkansas

Sponsors (1)
Lead Sponsor Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Brain function test 8 year old
Primary Language processing tests 8 year old
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