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Recruiting NCT03505216

Swiss Paediatric Airway Cohort

Conditions: Asthma Wheezing Cough Exercise Induced Bronchospasm Inspiratory Laryngeal Obstruction Dysfunctional Breathing

Sponsor: University of Bern

trial.available_in: БГ
Overview
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/
Description
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: Recruitment and participation: The SPAC study recruits patients aged 0-16 that are referred to a paediatric outpatient clinic for recurrent respiratory symptoms. Families receive a SPAC information package containing an invitation letter, study information leaflet, informed consent form, and questionnaire. Physicians introduce the study to them, answer questions, and collect informed consent forms. Completed questionnaires are brought by families to the clinics or sent directly by families to the SPAC study centre using a prepaid return envelope. Eligible patients have consultations in participating clinics regardless of their study participation. No tests are performed specifically for SPAC; examinations and tests are done only if clinically indicated or ordered by the referring physician. Examinations such as lung function, allergy, blood, or bronchial challenge tests are done using respective standard procedures in the clinics. SPAC research team members visit participating centres at regular intervals to collect data. During the first year, caregivers or patients who are 14 years or older receive short online questionnaire through a link via email. One year after enrolment and each year thereafter, caregivers receive a follow-up questionnaire by post. Information collected: Questionnaires: At baseline families complete a detailed questionnaire that includes sections on frequency, duration, severity, triggers, and history of upper and lower respiratory symptoms, and diagnoses, treatments, health behaviours, environmental factors, family history, and contact information. The monthly online questionnaires focus on symptoms, infections, and treatments which may change short-term. The yearly follow-up questionnaires focus on symptoms, treatments, and important risk factors during the past 12 months. Postal addresses for mailing are obtained from hospital records and updated by contacting community registration offices, a procedure used successfully for other registries and cohort studies in Switzerland. Questionnaires are currently available in German and French. Medical records: Information obtained from medical records includes reasons for referral; anthropometric measures; results from the physical examination and diagnostic tests including pulmonary function, aller
Who can participate
Inclusion Criteria: * 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 Exclusion Criteria: Prior diagnosis of cystic fibrosis, primary ciliary dyskinesia, severe heart disease, oncological disease, neuromuscular disease or severe disability
Locations 12
Austria (1)
Vienna Open Medical Institute
Vienna
COMPLETED
Switzerland (11)
Children's hospital Aarau
Aarau
ACTIVE_NOT_RECRUITING
University Children's hospital Basel, UKBB
Basel
Institute of Social and Preventive Medicine
Bern
University Children's Hospital Bern, Inselspital
Bern
Children's Hospital Chur
Chur
Pulmonology clinic, Horgen
Horgen
University Children's hospital Lausane, CHUV
Lausanne
Children's hospital Lucerne
Lucerne
Children's hospital St. Gallen
Sankt Gallen
ACTIVE_NOT_RECRUITING
Pulmonology clinic, Worb
Worb
University Children's Hospital Zurich
Zurich
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
0 Years
Maximum age
16 Years
Healthy volunteers
No
Start date
06.06.2017
Completion date
01.06.2030
Registry ID
NCT03505216
Source
clinicaltrials.gov
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