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Autism & Anesthetic Exposure Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03514498
Recruitment Status : Active, not recruiting
First Posted : May 2, 2018
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Mark Crawford, The Hospital for Sick Children

Tracking Information
First Submitted Date March 29, 2018
First Posted Date May 2, 2018
Last Update Posted Date February 2, 2021
Actual Study Start Date March 28, 2018
Actual Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 19, 2018)
  • Current language and behaviour skills [ Time Frame: up to 3 months before surgery ]
    measured using the Autism Diagnostic Interview - Revised
  • Regression in language and behaviour skills [ Time Frame: up to 12 weeks following anesthetic exposure ]
    measured using the Autism Diagnostic Interview - Revised
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 19, 2018)
  • Metabolic make-up [ Time Frame: immediately prior to anesthetic exposure ]
    measured using quantitative polymerase chain reactions
  • Metabolic changes [ Time Frame: within 1-2 hours following anesthetic exposure ]
    measured using quantitative polymerase chain reactions
  • Current non-specific behaviour skills [ Time Frame: up to 3 months before surgery ]
    measured using the Abberant Behaviour Checklist
  • Regression in non-specific behaviour skills [ Time Frame: up to 12 weeks following anesthetic exposure ]
    measured using the Abberant Behaviour Checklist
  • Current sleep habits [ Time Frame: up to 3 months before surgery ]
    measured using the Children's Sleep Habits Questionnaire
  • Regression in sleep habits [ Time Frame: up to 12 weeks following anesthetic exposure ]
    measured using the Children's Sleep Habits Questionnaire
  • Current social communication skills [ Time Frame: up to 3 months before surgery ]
    measured using the Social Communication Questionnaire
  • Regression in social communication skills [ Time Frame: up to 12 weeks following anesthetic exposure ]
    measured using the Social Communication Questionnaire
  • Current social responsiveness skills [ Time Frame: up to 3 months before surgery ]
    measured using the Social Responsiveness Scale
  • Regression in social responsiveness skills [ Time Frame: up to 12 weeks following anesthetic exposure ]
    measured using the Social Responsiveness Scale
  • Posthospitalization Behaviours [ Time Frame: 3 days following anesthetic exposure ]
    measured using the Posthospitalization Behaviour Questionnaire
  • Changes in posthospitalization behaviours [ Time Frame: up to 12 weeks following anesthetic exposure ]
    measured using semi-structured interview
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Autism & Anesthetic Exposure Study
Official Title Cognitive, Behavioural and Metabolic Effects of Anesthesia in Patients With Autism Spectrum Disorder: a Pilot Study
Brief Summary As anesthesia is often needed for childhood surgery and procedures, researchers have examined the potential effects of anesthesia on neurodevelopment. There are few studies that have examined the effect of anesthesia on neurodevelopment in children with confirmed diagnoses of ASD, and the results of these studies are mixed. Children with neurodevelopmental disorders can have age-dependent variations in brain anatomy, function, and connectivity, which may alter their sensitivity to the potential neurotoxic effects of anesthetic and sedative drugs. Given the potential adverse neurodevelopmental effects of anesthesia on typically developing children, it is important to examine if anesthesia exposure can worsen the clinical course of ASD.
Detailed Description

We hypothesize that children with a confirmed diagnosis of ASD will regress developmentally following general anesthesia for dental surgery in comparison to children without ASD (controls) undergoing dental surgery. In this pilot study, we will investigate this hypothesis through the following objectives:

  1. to determine in a clinical study if anesthesia induces post-operative persistent adverse changes children with ASD as compared with typically developing controls;
  2. to determine the potential mechanism for the adverse effects of anesthetics on patients with ASD compared to healthy controls, peripheral blood mononuclear cells will be isolated from blood samples (PBMCs), before genomic DNA isolation for mitochondrial content analysis.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Cell lines will be established from blood samples.
Sampling Method Non-Probability Sample
Study Population Children undergoing dental surgery at The Hospital for Sick Children
Condition Autism Spectrum Disorder
Intervention Procedure: Dental surgery
All types of dental surgery
Study Groups/Cohorts
  • Autism Spectrum Disorder
    Children aged 4-12 years with a clinical diagnosis of mild-to-moderate Autism Spectrum Disorder undergoing dental surgery
    Intervention: Procedure: Dental surgery
  • Typically Developed Controls
    Children with no neurodevelopmental delays matched to Autism Spectrum Disorder participants according to age (within 6 months), gender, and ASA physical status level, scheduled to undergo dental surgery
    Intervention: Procedure: Dental surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: January 29, 2021)
50
Original Estimated Enrollment
 (submitted: April 19, 2018)
60
Estimated Study Completion Date December 31, 2021
Actual Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria For Autism Spectrum Disorder Group:

  • child is undergoing dental surgery
  • child is aged 4 to 12 years
  • child has mild-to-moderate diagnosis of autism spectrum disorder
  • child has an American Society of Anesthesiologists (ASA) Physical Status level I or II

Exclusion Criteria for Autism Spectrum Disorder Group:

- child does not use words or phrases to communicate

Inclusion Criteria for Typically Developed Controls Group:

  • child is undergoing dental surgery
  • child is matched to an autism spectrum disorder participant according to age, gender, and ASA level
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years to 12 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03514498
Other Study ID Numbers 1000057105
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Mark Crawford, The Hospital for Sick Children
Study Sponsor The Hospital for Sick Children
Collaborators Not Provided
Investigators
Principal Investigator: Mark Crawford The Hospital for Sick Children
PRS Account The Hospital for Sick Children
Verification Date January 2021