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临床试验/NCT05765383
NCT05765383Enrolling By Invitation不适用

Prognosis and Influencing Factors of Asthma in Children Aged 5-12 Years

Guangzhou Institute of Respiratory Disease1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
400
试验地点
1
主要终点
Review and collation.

研究概览

简要总结

The goal of this observational study is to 1)analyze the basic information of confirmed cases of asthma in children aged 5-12 years old hospitalized in the First Affiliated Hospital of Guangzhou Medical University from 2009 to 2020, 2)investigate the onset of asthma after 13 years old, 3)conducte lung function, blood and airway inflammation indicators, blood IL13 and IL1RL1 levels, 4)analyze the prognosis and influencing factors of children with asthma in this age group.Participants will be asked to fill a case report form and questionnaires. Besides, they should provide examination results like lung function, total IgE, expired nitric oxide, blood and sputum granulocyte counts, and determination of blood IL13 and IL1RL1 levels over the past 6 months.

详细描述

Research methods:

Part I: Retrospective analysis of hospitalized cases of asthma in children aged 5-12 years old from 2009 to 2020: (1) General information of the children (gender, age and BMI); (2) Special medical history of parents; (3) The history of respiratory virus infection in the early life; (4) that age of the first occurrence of asthma; (5) The number of wheezes in the 12 months before the diagnosis of asthma; (6) Specificity; (7) trigger factors of symptoms; (8) Time pattern of symptom manifestations; (9) Illness severity; (10) Airway inflammation pattern; (11) Baseline of lung function; (12) Anti-inflammatory treatment; (13) Reactions to drug therapy. (14) coinfected diseases or complications. (15) Genetic information.

Part II: Patients who are lost to follow-up will be excluded. The patients will be divided into asthma relief group and asthma continuation group according to whether they had relapsed asthma after 13 years old. The case report form and C-ACT/ACT questionnaire will be filled out. Patients should provide examination results like lung function, total IgE, expired nitric oxide, blood and sputum granulocyte counts, and determination of blood IL13 and IL1RL1 levels over the past 6 months.

Part III: Univariate and multivariate analyses will be performed for different prognostic outcomes of asthma in children aged 5 to 12 years.

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
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalized children with asthma (age range 5-12 years old) from 2009 to 2020 in the First Affiliated Hospital of Guangzhou Medical University were collected. Diagnostic criteria were included by referring to global initiative for asthma and Guidelines for Diagnosis, Prevention and Treatment of Pediatric Bronchial Asthma revised in 2008.

排除标准

  • Children who declined follow-up
  • Children with pulmonary and tracheal dysplasia, bronchiolitis obliterans, and other conditions leading to wheezing

结局指标

主要结局

Review and collation.

时间窗: 2022.08-2022.10

To collect the case data of asthma in children aged 5 - 12 and analyze its clinical phenotype.

Case follow-up

时间窗: 2022.10-2022.12

The case report form and C-ACT/ACT questionnaire will be filled out. Patients should provide specific examination results.

Data analysis

时间窗: 2023.1-2023.2

Analyze the data obtained.

次要结局

未报告次要终点

研究者

发起方
Guangzhou Institute of Respiratory Disease
申办方类型
Other
责任方
Principal Investigator
主要研究者

LI-HONG SUN

Professor

Guangzhou Institute of Respiratory Disease

研究点 (1)

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