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Etiology and Early Diagnosis of Neurodevelopmental Disorders

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ClinicalTrials.gov Identifier: NCT02003170
Recruitment Status : Recruiting
First Posted : December 6, 2013
Last Update Posted : January 4, 2019
Sponsor:
Collaborator:
Arkansas Children's Hospital Research Institute
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
The purpose of this study is to systematically evaluate the results of medical investigations to identify symptom and biological patterns and common etiologies of neurodevelopmental disorders.

Condition or disease
Neurodevelopmental Disorders

Detailed Description:
Although neurodevelopmental disorders are very prevalent (for example Autism affects 1 out of every 88 children and dyslexia affects up to 15% of the population), the etiology of such disorders is not known. The purpose of this investigation is to identify common etiologies of neurodevelopmental disorders (i.e., speech delay, global developmental delay, autism) and determine if it is possible to find early indicators of the diagnosis and foster the potential for a better prognosis of these disorders. At this time the investigators examine patients with neurodevelopment disorders with various medical investigations, but the results of these investigations are not systematically evaluated. One of the goals of this research is to systematically examine this information in order to identify patterns of test abnormalities that have not been previously described. Another goal of this research is to identify the common etiologies typically identified by the medical evaluation, so we can further refine our approach. In addition, the investigators now have the ability to evaluate biological samples for biomarkers that have potential to be diagnostically useful.

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Etiology and Early Diagnosis of Neurodevelopmental Disorders
Study Start Date : May 2012
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Group/Cohort
Neurodevelopmental Disorders
Children who present to various Arkansas Children's Hospital clinics for standard care related to neurodevelopmental disorders.



Primary Outcome Measures :
  1. Medical abnormalities associated with specific neurodevelopmental disorders [ Time Frame: up to 7 years ]
    It is unknown if a specific set of biological abnormalities contribute to the formation of many types of neurodevelopmental disorders. The study is intended to identify the relationship between biological abnormalities and neurodevelopmental disorders


Secondary Outcome Measures :
  1. Biomarkers associated with neurodevelopmental disorders [ Time Frame: up to 7 years ]
    It is unknown if a specific biomarkers are associated with specific neurodevelopmental disorders. The study is intended to identify the relationship between biological abnormalities and neurodevelopmental disorders

  2. Treatments associated with neurodevelopmental disorders [ Time Frame: up to 7 years ]
    Various behavioral and medical treatments are used for many types of neurodevelopmental disorders but the effectiveness for many of these treatments is not known. The study is intended to identify the relationship between biological abnormalities (and their treatments) and neurodevelopmental disorders


Biospecimen Retention:   Samples With DNA
Blood, urine, cerebrospinal fluid, muscle, and skin samples may be retained.


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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children who present to various Arkansas Children's Hospital Outpatient clinics for standard care related to neurodevelopmental disorders.
Criteria

Inclusion Criteria:

  • Neurodevelopmental delays
  • Clinical visit at an Arkansas Children's Hospital Outpatient clinic

Exclusion Criteria:


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): NCT02003170


Contacts
Contact: Leanna M Delhey, MPH 501-364-4519 ldelhey@uams.edu

Locations
United States, Arkansas
Arkansas Children's Hospital Research Institute Recruiting
Little Rock, Arkansas, United States, 72205
Principal Investigator: Shannon Rose, PhD         
Sponsors and Collaborators
University of Arkansas
Arkansas Children's Hospital Research Institute
Investigators
Principal Investigator: Shannon Rose, PhD. Arkansas Children's Hospital Research Instisute; UAMS

Additional Information:
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02003170     History of Changes
Other Study ID Numbers: IRB #136272
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019

Keywords provided by University of Arkansas:
Autism
Autism Spectrum Disorder (ASD)
Pervasive Developmental Disorder (PDD)
Developmental delays
Genetic disorder
Mitochondrial disorder

Additional relevant MeSH terms:
Disease
Neurodevelopmental Disorders
Pathologic Processes
Mental Disorders