Actively Recruiting

Age: 1Minute - 42Days
All Genders
ID06327906

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

Led by Qilu Hospital of Shandong University · Updated on 2024-03-25

6000

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying a birth cohort of infants to understand how allergies might be linked to neurodevelopmental disorders such as autism spectrum disorder (ASD), attention deficit hyperactivity disorder (ADHD), and learning disabilities. The study aims to identify factors in early life that influence these neurodevelopmental outcomes using standard diagnostic criteria (DSM-5). This observational study is led by Qilu Hospital of Shandong University and focuses on children living in Jinan City and nearby areas in China. Infants in the study are divided into two groups based on allergy status: an allergic group and a control group without allergies. They will be followed for up to six years, with periodic collection of biological samples like blood, urine, and feces. Growth measurements such as height and weight, along with developmental assessments like the GESELL test, will be recorded during regular follow-ups. Participants will undergo evaluations to monitor for signs of ASD, ADHD, or learning disabilities over the study period. Researchers will gather data through questionnaires and clinical examinations at multiple time points from 2023 to 2029. This long-term follow-up helps assess how early-life allergies may affect neurodevelopment. The study provides ongoing monitoring but does not involve any treatment interventions.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 1Minute - 42Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Positive results on an allergy questionnaire
  • Living in Jinan City or surrounding areas in Shandong Province for convenient follow-up
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 6 years

Participants are followed up for up to 6 years with collection of specimens (blood, urine, feces) and test data (height, weight, developmental assessments).

Periodic visits over 6 years

Trial Site Locations

Total: 1 location

1

Qilu Hospital of Shandong University

Jinan, Shandong, China

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Research Team

C

cao aihua, post-doctoral

Z

zhu mengna, postgraduate

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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