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| ID | Type | Description | Link |
|---|---|---|---|
| CHZJU2025IIT006 | Other Grant/Funding Number | Children's Hospital, Zhejiang University School of Medicine |
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This study aims to evaluate the efficacy and safety of inhaled xenon for the treatment of children with autism spectrum disorder (ASD). The primary objective is to determine whether short-term inhalational xenon therapy can improve social functioning in children with ASD, as measured by changes in the Social Responsiveness Scale (SRS). Safety and tolerability of xenon inhalation in the pediatric population will also be assessed.
In this randomized, placebo-controlled trial, participants will receive either inhaled xenon or a placebo gas (medical air without xenon) to compare treatment effects.
Participants will:
Inhale 25% xenon or placebo for 10 minutes per day for 10 consecutive days Attend two clinical visits: one immediately after completion of the intervention and one at 3 months post-intervention for follow-up assessments and safety evaluations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants inhaled 30% oxygen, 10 min/day, for 10 days | Placebo Comparator | Children aged 4-8 years with autism spectrum disorder in the control group underwent a daily 10-minute inhalation of 30% oxygen (delivered via face mask at 2 L/min) for 10 consecutive days. |
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| Participants inhaled a mixture of 25% Xenon, 10 min/day, for 10 days | Experimental | Children aged 4-8 years with autism spectrum disorder in the treatment group underwent a daily 10-minute inhalation of 25% Xenon (delivered via face mask at 2 L/min) for 10 consecutive days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenon | Drug | Children aged 4-18 with autism spectrum disorder inhaled a mixture of 25% Xenon via a face mask at an oxygen flow rate of 2 L/min, for 10 minutes per day for 10 day. |
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| Measure | Description | Time Frame |
|---|---|---|
| Core symptom outcomes | For the assessment of core symptom outcomes, the social responsiveness scale, Second Edition was used.Raw scores were converted to age- and sex-normed T-scores, with a minimum obtainable T-score of 30. A total T-score of 60 or higher indicates clinically significant symptom severity, whereas T-scores of 59 or below are considered within the normal range. | From enrollment to the end of treatment at 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Core symptom outcomes | For the assessment of core symptom outcomes, the Autism Diagnostic Observation Schedule (ADOS-2) was used. | From enrollment to the end of treatment at 3 months. |
| Aberrant behavior outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin piao Zhu, Associate fellow | Contact | 0571-81732399 | zhujinpiao@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Affiliated to Zhejiang University School of Medicine (Binjiang Campus) | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014978 | Xenon |
| ID | Term |
|---|---|
| D005741 | Noble Gases |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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For the assessment of aberrant behavior outcomes, the Aberrant behavior Checklist (ABC) scale was used.
| From enrollment to the end of treatment at 3 months. |
| Treatment efficacy | For the assessment of treatment efficacy, the Autism Treatment Evaluation Checklist scale was used. The Autism Treatment Evaluation Checklist total score ranges from a minimum of 0 (no autism symptoms) to a maximum of 179 (severe impairment), with lower scores indicating fewer symptoms and higher scores indicating greater severity. | From enrollment to the end of treatment at 3 months. |
| Severity | For the assessment of behavioral severity, the Clinical Impressions Severity of illness (CGI-S) was used. | From enrollment to the end of treatment at 3 months. |
| Improvements | For the assessment of behavioral improvements after treatment, the Clinical Global Impressions scale for Improvement (CGI-I) scale was used.The Clinical Global Impressions-Improvement scale is a 7-point scale ranging from 1 ("Very much improved") to 7 ("Very much worse"), with a score of 4 indicating "No change." | From enrollment to the end of treatment at 3 months. |
| Sleep problems | For the assessment of sleep problems, the Children's Sleep Habits Questionnair (CSHQ) was used. | From enrollment to the end of treatment at 3 months. |
| Brain functions | For the assessment of brian functions, the MRI imaging was used. | From enrollment to the end of treatment at 3 months. |