Observational Prospective Study on Behavioral Outcomes of Children With Autism Spectrum Disorder (ASD) in Comparison to Those Without Neurodevelopmental Diagnoses

Boston Children's Hospital1 site in 1 country200 target enrollmentFebruary 2016

ConditionsAutism Spectrum Disorder Anesthesia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Autism Spectrum Disorder
Sponsor: Boston Children's Hospital
Enrollment: 200
Locations: 1
Primary Endpoint: Incidence of postoperative behavioral changes in the participants
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Autism Spectrum Disorder (ASD) is the fastest growing neurodevelopmental disorder in the world. Approximately 1% of the population worldwide is affected by this disorder. Children with ASD exhibit some very stereo-typical behaviors. Their daily functionality depends on very rigid and predictable schedules and routines. Any changes in their schedules can often trigger negative emotional outbursts. The need to come to the hospital for procedures can be one such trigger. The purpose of this study is to examine the post anesthesia behavior outcomes of children with ASD.

Registry

clinicaltrials.gov

Start Date

February 2016

End Date

December 2022

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Boston Children's Hospital

Responsible Party

Principal Investigator

Bistra Vlassakova

Boston Children's Hospital

Eligibility Criteria

Inclusion Criteria

•Patients aged 2 years through 17 years of age scheduled for a procedure with anesthesia at Boston Children's Hospital
•Patients must have a diagnosis of Autism Spectrum Disorder (ASD) according to the DSM IV and DSM V (autism group) or an ASA score of I or II and no history of neurodevelopmental concerns (control group)