Etiology and Early Diagnosis of Neurodevelopmental Disorders

NCT02003170 | Completed

• 1 other identifier: 136272
• Study Type: observational
• Target: 576
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodevelopmental Disorders

Keywords

Autism; Autism Spectrum Disorder (ASD); Pervasive Developmental Disorder (PDD); Developmental delays; Genetic disorder; Mitochondrial disorder

Outcome Measures

Primary Outcomes (1)

• Medical abnormalities associated with specific neurodevelopmental disorders

  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

  up to 7 years

Secondary Outcomes (2)

• Biomarkers associated with neurodevelopmental disorders

  up to 7 years

• Treatments associated with neurodevelopmental disorders

  up to 7 years

Study Arms (1)

Neurodevelopmental Disorders

Children who present to various Arkansas Children's Hospital clinics for standard care related to neurodevelopmental disorders.

Eligibility Criteria

• Age: 0 Months - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• University of Arkansas: lead
• Arkansas Children's Hospital Research Institute: collaborator

Study Sites (1)

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

• 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.

  PMID: 34645790 DERIVED

Related Links

• To see a list of current clinical Trials at Arkansas Children's Hospital, click here!!

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, cerebrospinal fluid, muscle, and skin samples may be retained.

MeSH Terms

Conditions

Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Genetic Diseases, Inborn; Mitochondrial Diseases

Condition Hierarchy (Ancestors)

Mental Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Shannon Rose, PhD.

  Arkansas Children's Hospital Research Instisute; UAMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 6, 2013
• Study Start: May 1, 2012
• Primary Completion: June 6, 2024
• Study Completion: June 6, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Locations

US (1)