Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT02707939

Conditions

Autism Spectrum Disorder

Anesthesia

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Accepted

Interventions

Observation

Study Details

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.

Conditions

Autism Spectrum Disorder

Anesthesia

Study ID

NCT02707939

Start date

Feb, 2016

Status verified date

Feb, 2022

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Accepted

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)

Exclusion Criteria:

-Families who are not able to read and speak English well enough to complete the validated surveys

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Autism Spectrum Disorder

Patients with a diagnosis of autism spectrum disorder

Controls

Patients with no developmental diagnoses

Interventions

Observation

Patients will be observed before and after they receive anesthesia

Primary outcome measure

  • Incidence of postoperative behavioral changes in the participants [ Time Frame: up to two weeks following anesthesia ]

Central Contacts and Locations

Central contacts

Erin Halpin, MSN, RN

857-218-4585erin.halpin@childrens.harvard.edu

Rachel Bernier, MPH

8572185348rachel.bernier@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Bistra Vlassakova, MD

bistra.vlassakova@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Feb 10, 2022

Last verified

Feb, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2022-02-10.