Clinical trial NCT02003170: Etiology and Early Diagnosis of Neurodevelopmental Disorders
Official title: Etiology and Early Diagnosis of Neurodevelopmental Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurodevelopmental Disorders
Keywords: Autism
Autism Spectrum Disorder (ASD)
Pervasive Developmental Disorder (PDD)
Developmental delays
Genetic disorder
Mitochondrial disorder
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Arkansas Children's Hospital Research Institute
First posted: 2013-12-06
Enrollment: 576
Sex: ALL
Minimum age (years): 0
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Medical abnormalities associated with specific neurodevelopmental disorders
timeFrame: up to 7 years
Secondary outcomes:
measure: Biomarkers associated with neurodevelopmental disorders
timeFrame: up to 7 years
measure: Treatments associated with neurodevelopmental disorders
timeFrame: up to 7 years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital Research Institute
state: Arkansas
Study officials:
affiliation: Arkansas Children's Hospital Research Instisute; UAMS
name: Shannon Rose, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frye RE, Lionnard L, Singh I, Karim MA, Chajra H, Frechet M, Kissa K, Racine V, Ammanamanchi A, McCarty PJ, Delhey L, Tippett M, Rose S, Aouacheria A. Mitochondrial morphology is associated with respiratory chain uncoupling in autism spectrum disorder. Transl Psychiatry. 2021 Oct 13;11(1):527. doi: 10.1038/s41398-021-01647-6.