DRKS00015738招募中未知
Description of mechanistic processes and detection of novel biomarkers during exacerbation in children and adolescents with bronchial asthma and chronic bronchitis/Wheeze.
Zentrum für Kinder- und Jugendmedizin, Zentrum für Forschung in der Klinischen Medizin, Helios Universitätsklinikum Wuppertal, Universität Witten/Herdecke0 个研究点目标入组 300 人开始时间: 2018年10月31日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 3 Months 至 65 Years（—）
- 性别
- All
入选标准
- •The following inclusion criteria apply to the asthma cohort: Study patients with previously diagnosed bronchial asthma who are between = 5-6 and < 18 years of age can be included. In addition, study patients with a previously undiagnosed bronchial asthma but with a history of asthma typical symptoms and with current respiratory symptoms (in the sense of an initial diagnosis) can also be included. The diagnosis of bronchial asthma is based on national and international guidelines (GINA, ISAAC, NVL). See also the exact diagnostic criteria for bronchial asthma in the literature. In addition, there must be no preterm birth and a partus = 37. SSW must have taken place. Other underlying diseases as well as postnatal respiratory adaptation disorders are considered as exclusion criteria.
- •The inclusion criteria of the Wheezer cohort are as follows. Subjects with recurrent obstructive bronchitis episodes between the = 3. months to = 5./6. year of life with at least 2 obstructive bronchitis episodes, at least one outpatient and one inpatient treatment (the current inpatient presentation can also be considered as one disease episode) fulfill the inclusion criteria. Since this cohort description and the diagnosis in the literature are quite heterogeneous, we have decided on this number of disease episodes. Furthermore, the same exclusion criteria apply as for the asthma cohort.
- •For the so-called healthy cohort, the following inclusion criteria apply: healthy children and adolescents between the age of = 3 months and < 65 years with no underlying chronic disease, no postnatal adaptation included, no mechanical respiratory support, and no developmental delay, no long-term medication, and no febrile infection in the last 3 weeks.
排除标准
- •See also inclusion criteria, furthermore missing inclusion criteria and
- •Lack of consent of the patient or guardian.
研究者
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