Infant Diet Effects on Brain Function and Language Processing (fMRI)
This study is currently recruiting participants.
Verified January 2013 by Arkansas Children's Hospital Research Institute
Sponsor:
Arkansas Children's Hospital Research Institute
Collaborators:
University of Arkansas
USDA Beltsville Human Nutrition Research Center
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00735423
First received: August 14, 2008
Last updated: January 28, 2013
Last verified: January 2013
| Tracking Information | |||||
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| First Received Date ICMJE | August 14, 2008 | ||||
| Last Updated Date | January 28, 2013 | ||||
| Start Date ICMJE | August 2008 | ||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To test brain function and language processing in 8 year old children [ Time Frame: 8 year old ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00735423 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Infant Diet Effects on Brain Function and Language Processing (fMRI) | ||||
| Official Title ICMJE | Effects of Neonatal Diet on Language, Neurocognitive Functions at Eight Years Old: fMRI, ERP and Standardized Behavioral Measures | ||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | healthy 8-year-old children |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Device: No intervention
IDE used for outcome measurement not intervention |
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| Study Group/Cohort (s) | No groups
IDE used for outcome measurement not intervention
Intervention: Device: No intervention |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | May 2013 | ||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 90 Months to 101 Months | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00735423 | ||||
| Other Study ID Numbers ICMJE | 77556 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Arkansas Children's Hospital Research Institute | ||||
| Study Sponsor ICMJE | Arkansas Children's Hospital Research Institute | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Arkansas Children's Hospital Research Institute | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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