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

NCT ID: NCT06327906

Last Updated: 2024-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-15

Study Completion Date

2029-11-15

Brief Summary

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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

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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.

Conditions

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Child Allergy Neurodevelopmental Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

1 Minute

Maximum Eligible Age

42 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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cao aihua, post-doctoral

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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cao aihua, post-doctoral

Role: CONTACT

18560086317

zhu mengna, postgraduate

Role: CONTACT

15211482407

Facility Contacts

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zhu mengna

Role: primary

15211482407

Other Identifiers

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qilu000002

Identifier Type: -

Identifier Source: org_study_id

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