Clinical trial NCT04358744: The Real World Study of Autism Spectrum Disorder in China
Official title: The Real World Study of Children With Autism Spectrum Disorder in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism Spectrum Disorder
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with autism spectrum disorder have registered in Xinhua hospital and provided written informed consent from themselves and/or their legal guardians.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* NA

Primary outcomes:
measure: Behaviour assessment
timeFrame: The baseline and 3 months
Secondary outcomes:
Other outcomes:
measure: Genetic characteristics
timeFrame: The baseline
measure: Blood test
timeFrame: The baseline and 3 months
measure: Blood test
timeFrame: The baseline and 6 months
measure: Blood test
timeFrame: The baseline and 12 months
measure: Gut mircobiome
timeFrame: The baseline and 1 months
measure: Gut mircobiome
timeFrame: The baseline and 3 months
measure: Gut mircobiome
timeFrame: The baseline and 6 months
measure: Gut mircobiome
timeFrame: The baseline and 12 months
measure: Head Magnetic Resonance Imaging (Head MRI)
timeFrame: The baseline and 3 months
measure: Head Magnetic Resonance Imaging (Head MRI)
timeFrame: The baseline and 12 months
measure: Functional near - infrared spectroscopy(f-NIRS)
timeFrame: The baseline and 3 months
measure: Functional near - infrared spectroscopy(f-NIRS)
timeFrame: The baseline and 6 months
measure: Functional near - infrared spectroscopy(f-NIRS)
timeFrame: The baseline and 12 months
measure: Multichannel Electroencephalography signals
timeFrame: The baseline and 3 months
measure: Multichannel Electroencephalography signals
timeFrame: The baseline and 6 months
measure: Multichannel Electroencephalography signals
timeFrame: The baseline and 12 months
measure: Eye movements
timeFrame: The baseline and 3 months
measure: Eye movements
timeFrame: The baseline and 6 months
measure: Eye movements
timeFrame: The baseline and 12 months
measure: Behaviour assessment
timeFrame: The baseline and 6 months
measure: Behaviour assessment
timeFrame: The baseline and 12 months
Locations:
city: Shanghai
country: China
facility: ShanghaiXinhua
state: Shanghai
Study officials:
affiliation: Xinhua hospital Affilated to Shanghai Jiao Tong University School of Medicine
name: Fei Li, doctor
role: PRINCIPAL_INVESTIGATOR
References: