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

Recruiting
Conditions
Child Allergy
Neurodevelopmental Disorders
Registration Number
NCT06327906
Lead Sponsor
Qilu Hospital of Shandong University
Brief 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.

Detailed 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 & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
6000
Inclusion Criteria
  • ①Allergic 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 ④Major physical diseases ⑤Visual and auditory disorders ⑥ Epilepsy ⑦Intellectual disabilities

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
ASDfrom 2023-11-15 to 2026-11-15

with diagnostic criteria of DSM-V ASD, and ADOS, CARS auxiliary diagnosis.

ADHDfrom 2023-11-15 to 2029-11-15

with diagnostic criteria of DSM-V ADHD, and SNAP-Ⅳ, CONNER auxiliary diagnosis.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Qilu Hospital of Shandong University

🇨🇳

Jinan, Shandong, China

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