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NCT06327906 Clinical Trial

A Prospective Birth Cohort of Infants With Allergy and Neurodevelopmental Disorders in China

Neurodevelopmental Disorders Clinical Trial

Official title:
A Series of Studies Based on a Prospective Birth Cohort of Infants With Allergy and Neurodevelopmental Disorders in China

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06327906
Other study ID # qilu000002
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 15, 2023
Est. completion date November 15, 2029

Study information
Verified date October 2023
Source Qilu Hospital of Shandong University
Contact cao aihua, post-doctoral
Phone 18560086317
Email xinercah@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study, a birth cohort was established to demonstrate the causal relationship between allergies and neurodevelopment disorders in infants and young children, and to find out the influencing factors of neurodevelopment disorders in early life.

Description:

In this study, a birth cohort was established, and infants were divided into two groups according to inclusion and exclusion criteria ( see study design ). One group was allergic group, and the other group was control group. The two groups will be followed up for up to 6 years, and specimens ( blood, urine, feces ) and test data ( height, weight, GESELL, etc. ) will be retained during the follow-up period. The outcome indicators were ASD, ADHD or LD, and DSM-5 was used as the diagnostic criteria.

Recruitment information / eligibility
Status Recruiting
Enrollment 6000
Est. completion date November 15, 2029
Est. primary completion date November 15, 2026
Accepts healthy volunteers
Gender All
Age group 1 Minute to 42 Days
Eligibility Inclusion Criteria: - ?Allergic questionnaire results were positive. - The living area is Jinan City and its surrounding areas in Shandong Province, which is convenient for follow-up. Exclusion Criteria: - There is a clear diagnosis of brain developmental disorders - Psychological diseases - History of craniocerebral trauma or brain organic disease ?Major physical diseases ?Visual and auditory disorders ? Epilepsy ?Intellectual disabilities

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Qilu Hospital of Shandong University Jinan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary ASD with diagnostic criteria of DSM-V ASD, and ADOS, CARS auxiliary diagnosis. from 2023-11-15 to 2026-11-15
Primary ADHD with diagnostic criteria of DSM-V ADHD, and SNAP-?, CONNER auxiliary diagnosis. from 2023-11-15 to 2029-11-15
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