A Series of Studies Based on a Prospective Birth Cohort of Infants With Allergy and Neurodevelopmental Disorders in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- ASD
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Minute 至 42 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •①Allergic questionnaire results were positive.
- •The living area is Jinan City and its surrounding areas in Shandong Province, which is convenient for follow-up.
排除标准
- •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
结局指标
主要结局
ASD
时间窗: from 2023-11-15 to 2026-11-15
with diagnostic criteria of DSM-V ASD, and ADOS, CARS auxiliary diagnosis.
ADHD
时间窗: from 2023-11-15 to 2029-11-15
with diagnostic criteria of DSM-V ADHD, and SNAP-Ⅳ, CONNER auxiliary diagnosis.
次要结局
未报告次要终点