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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00735423
First Posted: August 15, 2008
Last Update Posted: June 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
  Purpose
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.

Condition Intervention
Healthy Device: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Effects of Neonatal Diet on Language, Neurocognitive Functions at Eight Years Old: fMRI, ERP and Standardized Behavioral Measures

Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:
  • Brain function test [ Time Frame: 8 year old ]
  • Language processing tests [ Time Frame: 8 year old ]

Estimated Enrollment: 100
Actual Study Start Date: August 2008
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No groups
IDE used for outcome measurement not intervention
Device: No intervention
IDE used for outcome measurement not intervention

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   90 Months to 101 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy 8-year-old children
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735423


Locations
United States, Arkansas
Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
Principal Investigator: Xiawei Ou, Ph.D. Arkansas Children's Nutrition Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00735423     History of Changes
Other Study ID Numbers: 77556
First Submitted: August 14, 2008
First Posted: August 15, 2008
Last Update Posted: June 29, 2017
Last Verified: June 2017

Keywords provided by Arkansas Children's Hospital Research Institute:
Healthy children
Brain Function
Diet
Nutrition
Language
fMRI
ERP
Behavior