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Recruiting NCT06327906

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

Observational Child Allergy Neurodevelopmental Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Child Allergy, Neurodevelopmental Disorders. Basic parameters: 1 Minute — 42 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • ASD [Time frame: from 2023-11-15 to 2026-11-15]
  • ADHD [Time frame: from 2023-11-15 to 2029-11-15]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Qilu Hospital of Shandong University — Jinan

Identifiers

NCT: NCT06327906 · qilu000002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗