The Real World Study of Autism Spectrum Disorder in China

The Real World Study of Children With Autism Spectrum Disorder in China

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

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder

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 Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

• Study Contact: Name: Fei Li, doctor; Phone Number: +86-21-25077461; Email: feili@shsmu.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Recruiting
      • ShanghaiXinhua
      • Contact: Fei Li, Director

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 16 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• NA

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behaviour assessment	The behaviour development of participants includes intellectual/developmental quotient, syptoms severity, comorbidity, etc.	The baseline and 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genetic characteristics	Genome wide association study from blood sample	The baseline
Blood test	Retained blood samples tested in immunomics, metabonomics, etc	The baseline and 3 months
Blood test	Retained blood samples tested in immunomics, metabonomics, etc	The baseline and 6 months
Blood test	Retained blood samples tested in immunomics, metabonomics, etc	The baseline and 12 months
Gut mircobiome	Retained stool samples tested in metabonomics, genomics, etc	The baseline and 1 months
Gut mircobiome	Retained stool samples tested in metabonomics, genomics, etc	The baseline and 3 months
Gut mircobiome	Retained stool samples tested in metabonomics, genomics, etc	The baseline and 6 months
Gut mircobiome	Retained stool samples tested in metabonomics, genomics, etc	The baseline and 12 months
Head Magnetic Resonance Imaging (Head MRI)	Head MRI is used to detect the structure and function of the brain.	The baseline and 3 months
Head Magnetic Resonance Imaging (Head MRI)	Head MRI is used to detect the structure and function of the brain.	The baseline and 12 months
Functional near - infrared spectroscopy(f-NIRS)	Head fNIRs is a non-invasive, non-ionizing method for measuring and imaging the functional hemodynamic response to brain activity. It measures changes in hemoglobin (Hb) concentrations within the brain by means of the characteristic absorption spectra of Hb in the near-infrared range.	The baseline and 3 months
Functional near - infrared spectroscopy(f-NIRS)	Head fNIRs is a non-invasive, non-ionizing method for measuring and imaging the functional hemodynamic response to brain activity. It measures changes in hemoglobin (Hb) concentrations within the brain by means of the characteristic absorption spectra of Hb in the near-infrared range.	The baseline and 6 months
Functional near - infrared spectroscopy(f-NIRS)	Head fNIRs is a non-invasive, non-ionizing method for measuring and imaging the functional hemodynamic response to brain activity. It measures changes in hemoglobin (Hb) concentrations within the brain by means of the characteristic absorption spectra of Hb in the near-infrared range.	The baseline and 12 months
Multichannel Electroencephalography signals	The latency and amplitude measured by electroencephalogram can reflect the connectivity between brain regions.	The baseline and 3 months
Multichannel Electroencephalography signals	The latency and amplitude measured by electroencephalogram can reflect the connectivity between brain regions.	The baseline and 6 months
Multichannel Electroencephalography signals	The latency and amplitude measured by electroencephalogram can reflect the connectivity between brain regions.	The baseline and 12 months
Eye movements	Variables measured by eye movements represent cognition.	The baseline and 3 months
Eye movements	Variables measured by eye movements represent cognition.	The baseline and 6 months
Eye movements	Variables measured by eye movements represent cognition.	The baseline and 12 months
Behaviour assessment	The behaviour development of participants includes intellectual/developmental quotient, syptoms severity, comorbidity, etc.	The baseline and 6 months
Behaviour assessment	The behaviour development of participants includes intellectual/developmental quotient, syptoms severity, comorbidity, etc.	The baseline and 12 months

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Fei Li, doctor, Xinhua hospital Affilated to Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2019
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: XH-20-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No