The Real World Study of Autism Spectrum Disorder in China

Recruiting

• Conditions: Autism Spectrum Disorder

• Registration Number: NCT04358744
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

The investigators conduct the real world study to explore mechanisms of autism based on multi-modal data.

Detailed Description

Children with autism spectrum disorder registered in Xinhua Hospital are measured in aspects of behavioural accessment, genetic test, blood lab test, gut microbiome and neuroimaging including structural and functional magnetic resonance imaging (MRI), functional near - infrared spectroscopy(f-NIRS), electroencephalography and eye movement. The investigators conduct the real world study to explore mechanisms of autism based on the multi-modal data.

Study Timeline

• Study Start: 2019-04-13
• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-20
• Study First Posted: 2020-04-24
• Status Verified: 2021-04
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-10-29
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

• diagnosed with autism spectrum disorder
• registered in Xinhua hospital
• written informed consent provided

Exclusion Criteria

• NA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Behaviour assessment	The baseline and 3 months	The behaviour development of participants includes intellectual/developmental quotient, syptoms severity, comorbidity, etc.

Trial Locations

Locations (1)

ShanghaiXinhua; 🇨🇳 Shanghai, Shanghai, China