The Real World Study of Autism Spectrum Disorder in China

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04358744
• Other study ID #: XH-20-005
• Status: Recruiting
• Start date: April 13, 2019
• Est. completion date: September 2024

Study information

• Verified date: April 2021
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Fei Li, doctor
• Phone: +86-21-25077461
• Email: feili[@]shsmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Gender: All
• Age group: 18 Months to 18 Years

Eligibility

Inclusion Criteria:

• diagnosed with autism spectrum disorder

• registered in Xinhua hospital

• written informed consent provided

Exclusion Criteria:

• NA

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Locations

Country	Name	City	State
China	ShanghaiXinhua	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Genetic characteristics	Genome wide association study from blood sample	The baseline
Other	Blood test	Retained blood samples tested in immunomics, metabonomics, etc	The baseline and 3 months
Other	Blood test	Retained blood samples tested in immunomics, metabonomics, etc	The baseline and 6 months
Other	Blood test	Retained blood samples tested in immunomics, metabonomics, etc	The baseline and 12 months
Other	Gut mircobiome	Retained stool samples tested in metabonomics, genomics, etc	The baseline and 1 months
Other	Gut mircobiome	Retained stool samples tested in metabonomics, genomics, etc	The baseline and 3 months
Other	Gut mircobiome	Retained stool samples tested in metabonomics, genomics, etc	The baseline and 6 months
Other	Gut mircobiome	Retained stool samples tested in metabonomics, genomics, etc	The baseline and 12 months
Other	Head Magnetic Resonance Imaging (Head MRI)	Head MRI is used to detect the structure and function of the brain.	The baseline and 3 months
Other	Head Magnetic Resonance Imaging (Head MRI)	Head MRI is used to detect the structure and function of the brain.	The baseline and 12 months
Other	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
Other	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
Other	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
Other	Multichannel Electroencephalography signals	The latency and amplitude measured by electroencephalogram can reflect the connectivity between brain regions.	The baseline and 3 months
Other	Multichannel Electroencephalography signals	The latency and amplitude measured by electroencephalogram can reflect the connectivity between brain regions.	The baseline and 6 months
Other	Multichannel Electroencephalography signals	The latency and amplitude measured by electroencephalogram can reflect the connectivity between brain regions.	The baseline and 12 months
Other	Eye movements	Variables measured by eye movements represent cognition.	The baseline and 3 months
Other	Eye movements	Variables measured by eye movements represent cognition.	The baseline and 6 months
Other	Eye movements	Variables measured by eye movements represent cognition.	The baseline and 12 months
Other	Behaviour assessment	The behaviour development of participants includes intellectual/developmental quotient, syptoms severity, comorbidity, etc.	The baseline and 6 months
Other	Behaviour assessment	The behaviour development of participants includes intellectual/developmental quotient, syptoms severity, comorbidity, etc.	The baseline and 12 months
Primary	Behaviour assessment	The behaviour development of participants includes intellectual/developmental quotient, syptoms severity, comorbidity, etc.	The baseline and 3 months