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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06327906
Enrollment
6000
Registered
2024-03-25
Start date
2023-11-15
Completion date
2029-11-15
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Allergy, Neurodevelopmental Disorders

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.

Interventions

None listed

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 42 Days

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

Design outcomes

Primary

MeasureTime frameDescription
ASDfrom 2023-11-15 to 2026-11-15with diagnostic criteria of DSM-V ASD, and ADOS, CARS auxiliary diagnosis.
ADHDfrom 2023-11-15 to 2029-11-15with diagnostic criteria of DSM-V ADHD, and SNAP-Ⅳ, CONNER auxiliary diagnosis.

Countries

China

Contacts

Primary Contactcao aihua, post-doctoral
xinercah@163.com18560086317
Backup Contactzhu mengna, postgraduate
15211482407

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026