Prevention of CF exacerbation in childhood (PREVEC-study): early recognition by non-invasive biomarkers in exhaled breath (condensate) and early antibiotic treatment
Completed
- Conditions
- CFcystic fibrosis10006436
- Registration Number
- NL-OMON38104
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 49
Inclusion Criteria
Children with CF aged 5-18 years will be recruited.
CF disease is defined as the combination of: 1) characteristic clinical features (persistent pulmonary symptoms, meconium ileus, failure to thrive, steatorrhoe); 2) and/or abnormal sweat test (chloride > 60mM); 3) and/or two CF mutations.
Exclusion Criteria
Exclusion criteria are: 1) cardiac abnormalities; 2) mental retardation; 3) no technical satisfactory performance of measurements; 4) on the waiting list for lung transplantation; 5) non-compliance with the home-assessments; 6) patients with Burkholderia Cepacia; 7) participation in another intervention trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome measures: exacerbations (the time until the first exacerbation,<br /><br>the number of exacerbations) and lung function (forced expiratory volume in one<br /><br>second, FEV1 % predicted value). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures are respiratory symptoms, quality of life (CFQ),<br /><br>antibiotic resistance of cultured sputum bacteria, CT imaging, antibiotic<br /><br>courses, failures of exacerbation prediction, and hospital admission.</p><br>