Observing the link between allergies and neurodevelopmental disorders in infants in China
Official title: A Series of Studies Based on a Prospective Birth Cohort of Infants With Allergy and Neurodevelopmental Disorders in China
Run by Qilu Hospital of Shandong University · NCT06327906 · Data updated 2026-11-12
This study looks at whether allergies in infants are linked to developmental issues like autism and ADHD to help understand how they might affect young children's growth and learning.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Minute to 42 Days |
| Sex | All |
| Enrollment | 6000 (estimated) |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Status | Recruiting |
| Started | November 15, 2023 |
| Main results expected | November 15, 2026 |
| Study ends | November 15, 2029 |
| Registry record updated | March 25, 2024 |
| Trial ID | NCT06327906 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants living in Jinan City and surrounding areas who have tested positive for allergies.
✕Probably not a fit
Patients with pre-existing brain developmental disorders or significant psychological conditions will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study establishes a birth cohort to investigate the causal relationship between allergies and neurodevelopmental disorders in infants and young children. Infants will be divided into an allergic group and a control group based on specific inclusion and exclusion criteria. Over a follow-up period of up to six years, various specimens (blood, urine, feces) and test data (height, weight, developmental assessments) will be collected. The study aims to identify influencing factors on neurodevelopmental disorders such as ASD, ADHD, and learning disabilities using DSM-5 diagnostic criteria.
Why it matters
Potential benefit: If successful, this study could provide insights into the prevention and management of neurodevelopmental disorders in children with allergies.
How similar studies have gone: While the relationship between allergies and neurodevelopmental disorders has been explored, this specific cohort approach is relatively novel and may provide new insights.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Qilu Hospital of Shandong University
Jinan, Shandong, China Recruiting
Study contacts
- Principal investigator: cao aihua, post-doctoral — Qilu Hospital of Shandong University
- Study coordinator: cao aihua, post-doctoral
- Email: xinercah@163.com
- Phone: 18560086317
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.