Autism Spectrum DisorderNCT03514498
Autism & Anesthetic Exposure Study
An observational study of Autism Spectrum Disorder, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Dental surgery
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- 28 Mar 2018to 31 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children undergoing dental surgery at The Hospital for Sick Children
Who may be able to join
- 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
- child is undergoing dental surgery
- child is matched to an autism spectrum disorder participant according to age, gender, and ASA level
Who cannot join
- child does not use words or phrases to communicate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive, Behavioural and Metabolic Effects of Anesthesia in Patients With Autism Spectrum Disorder: a Pilot Study
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.
Read the 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:
- to determine in a clinical study if anesthesia induces post-operative persistent adverse changes children with ASD as compared with typically developing controls;
- 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Dental surgery
- Keywords
- anesthesia
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental surgeryProcedure or surgery
All types of dental surgery
| Study group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorder | Children aged 4-12 years with a clinical diagnosis of mild-to-moderate Autism Spectrum Disorder undergoing dental surgery Receives: 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 Receives: Procedure: Dental surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current language and behaviour skills
measured using the Autism Diagnostic Interview - Revised
Measured: up to 3 months before surgery
Regression in language and behaviour skills
measured using the Autism Diagnostic Interview - Revised
Measured: up to 12 weeks following anesthetic exposure
Secondary outcomes (12)
Metabolic make-up
measured using quantitative polymerase chain reactions
Measured: immediately prior to anesthetic exposure
Metabolic changes
measured using quantitative polymerase chain reactions
Measured: within 1-2 hours following anesthetic exposure
Current non-specific behaviour skills
measured using the Abberant Behaviour Checklist
Measured: up to 3 months before surgery
Regression in non-specific behaviour skills
measured using the Abberant Behaviour Checklist
Measured: up to 12 weeks following anesthetic exposure
Current sleep habits
measured using the Children's Sleep Habits Questionnaire
Measured: up to 3 months before surgery
Regression in sleep habits
measured using the Children's Sleep Habits Questionnaire
Measured: up to 12 weeks following anesthetic exposure
Current social communication skills
measured using the Social Communication Questionnaire
Measured: up to 3 months before surgery
Regression in social communication skills
measured using the Social Communication Questionnaire
Measured: up to 12 weeks following anesthetic exposure
Current social responsiveness skills
measured using the Social Responsiveness Scale
Measured: up to 3 months before surgery
Regression in social responsiveness skills
measured using the Social Responsiveness Scale
Measured: up to 12 weeks following anesthetic exposure
Posthospitalization Behaviours
measured using the Posthospitalization Behaviour Questionnaire
Measured: 3 days following anesthetic exposure
Changes in posthospitalization behaviours
measured using semi-structured interview
Measured: up to 12 weeks following anesthetic exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start28 Mar 2018
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Crawford, The Hospital for Sick Children
- Investigators
- Mark Crawford, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514498
- Sponsor's protocol ID
- 1000057105
- Status last verified
- Dec 2021
- First submitted
- 29 Mar 2018
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive, Behavioural and Metabolic Effects of Anesthesia in Patients With Autism Spectrum Disorder: a Pilot Study
- ClinicalTrials.gov ID
- NCT03514498
- Acronym / sponsor ID
- 1000057105
- Conditions
- Autism Spectrum Disorder
- Keywords
- anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to determine in a clinical study if anesthesia induces post-operative persistent adverse changes children with ASD as compared with typically developing controls;
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorder | – | Procedure: Dental surgeryChildren aged 4-12 years with a clinical diagnosis of mild-to-moderate Autism Spectrum Disorder undergoing dental surgery |
| Typically Developed Controls | – | Procedure: Dental surgeryChildren 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 |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children undergoing dental surgery at The Hospital for Sick Children
Key inclusion criteria (6 listed)
- 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
- child is undergoing dental surgery
Key exclusion criteria (1 listed)
- child does not use words or phrases to communicate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental surgeryAll types of dental surgery | Procedure or surgery | Autism Spectrum Disorder, Typically Developed Controls |
Primary outcome
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
12 secondary outcomes
Metabolic make-up
Time frame: immediately prior to anesthetic exposure
Metabolic changes
Time frame: within 1-2 hours following anesthetic exposure
Current non-specific behaviour skills
Time frame: up to 3 months before surgery
Regression in non-specific behaviour skills
Time frame: up to 12 weeks following anesthetic exposure
Current sleep habits
Time frame: up to 3 months before surgery
Regression in sleep habits
Time frame: up to 12 weeks following anesthetic exposure
Current social communication skills
Time frame: up to 3 months before surgery
Regression in social communication skills
Time frame: up to 12 weeks following anesthetic exposure
Current social responsiveness skills
Time frame: up to 3 months before surgery
Regression in social responsiveness skills
Time frame: up to 12 weeks following anesthetic exposure
Posthospitalization Behaviours
Time frame: 3 days following anesthetic exposure
Changes in posthospitalization behaviours
Time frame: up to 12 weeks following anesthetic exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Crawford principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Current language and behaviour skills (time frame: up to 3 months before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.