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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Arkansas Children's Hospital Research Institute
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00735423
First received: August 14, 2008
Last updated: November 11, 2015
Last verified: November 2015

August 14, 2008
November 11, 2015
August 2008
June 2017   (final data collection date for primary outcome measure)
  • Brain function test [ Time Frame: 8 year old ] [ Designated as safety issue: No ]
  • Language processing tests [ Time Frame: 8 year old ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00735423 on ClinicalTrials.gov Archive Site
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Infant Diet Effects on Brain Function and Language Processing (fMRI)
Effects of Neonatal Diet on Language, Neurocognitive Functions at Eight Years Old: fMRI, ERP and Standardized Behavioral Measures
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample
healthy 8-year-old children
Healthy
Device: No intervention
IDE used for outcome measurement not intervention
No groups
IDE used for outcome measurement not intervention
Intervention: Device: No intervention
Ou X, Andres A, Cleves MA, Pivik RT, Snow JH, Ding Z, Badger TM. Sex-specific association between infant diet and white matter integrity in 8-y-old children. Pediatr Res. 2014 Dec;76(6):535-43. doi: 10.1038/pr.2014.129. Epub 2014 Aug 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2017
June 2017   (final data collection date for primary outcome measure)

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
Both
90 Months to 101 Months
Yes
Contact: Jill Harsch, BS 501-364-3309 acncstudies@uams.edu
United States
 
NCT00735423
77556
No
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Arkansas Children's Hospital Research Institute
Arkansas Children's Hospital Research Institute
Not Provided
Principal Investigator: Xiawei Ou, Ph.D. Arkansas Children's Nutrition Center
Arkansas Children's Hospital Research Institute
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP