Swiss Paediatric Airway Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,000
- 试验地点
- 17
- 主要终点
- Wheeze
研究概览
简要总结
The Swiss Paediatric Airway Cohort (SPAC) is a national, prospective clinical cohort of children and adolescents who visit physicians in Switzerland for recurrent wheeze, cough, and exercise- or sleep-related respiratory problems. SPAC aims to answer important questions on clinical phenotypes, prognosis, diagnosis and treatment. SPAC is part of routine care, and only clinically indicated investigations are done. The comprehensive baseline assessment includes a detailed questionnaire to families, plus test results, diagnoses and treatments from hospital records. Follow-up is via monthly questionnaires the first 12 months and thereafter annual questionnaires to families, and data from follow-up visits.
Currently, 4344 patients from 10 clinics and hospitals in Switzerland (Aarau, Basel, Bern, Chur, Horgen, Lausanne, Luzern, St. Gallen, Worb, Zurich) have been enrolled.
SPAC provides real-life data on children visiting the Swiss health care system for common respiratory problems. It will provide a research platform for health services research, and for nested clinical and transitional studies.
Publications and plain language summaries are listed on the study website: https://www.spac-study.ch/publikationen/
详细描述
Background:
Many studies have investigated the epidemiology of asthma in childhood, but most were based on data from the general population gathered either in cross-sectional or longitudinal surveys in schoolchildren.
Objectives:
The Swiss Paediatric Airway Cohort (SPAC) was set up in 2017 as a large, longitudinal database that is representative of children and adolescents visiting physicians in Switzerland for recurrent wheeze, cough, and exercise- or sleep-related respiratory symptoms. It will constitute a national research platform for studying healthcare provision, phenotypes and prognosis of these problems, and a sampling frame for conducting nested studies.
Methods:
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
- 0 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents aged 0-16 years
- •Resident in Switzerland
- •Seen in a paediatric pulmonary outpatient clinic due to respiratory problems
- •Parents and patients above age 14 must be able to sign an informed consent form
排除标准
- •Prior diagnosis of cystic fibrosis, primary ciliary dyskinesia, severe heart disease, oncological disease, neuromuscular disease or severe disability
研究组 & 干预措施
Patient population
Children referred to paediatric pulmonary outpatient clinics for respiratory symptoms such as wheeze, cough, dyspnea, exercise- and sleep-related breathing problems.
结局指标
主要结局
Wheeze
时间窗: 1 year from inclusion in SPAC study
Number of patients with current wheeze as measured with questionnaire
Reduced lung function
时间窗: 1 year from inclusion in SPAC study
Number of patients with reduced lung function measured through clinical tests in the paediatric pulmonary clinics (Spirometry, Fraction of Exhaled Nitric Oxide, Bronchial challenge test, Exercise challenge test). Information collected through hospital records.
Cough apart from colds
时间窗: 1 year from inclusion in SPAC study
Number of patients with cough apart from colds as measured with questionnaires
Exercise-induced dyspnea
时间窗: 1 year from inclusion in SPAC study
Number of patients with exercise-induced dyspnea as measured with questionnaires
次要结局
- Exercise-induced dyspnea(5 years from inclusion in SPAC study)
- Wheeze(5 years from inclusion in SPAC study)
- Cough apart from colds(5 years from inclusion in SPAC study)
- Reduced lung function(5 years from inclusion in SPAC study)