Prevention of CF Exacerbation in Childhood: PREVEC Study

Maastricht University Medical Center49 enrolled

Overview

Pulmonary exacerbations of CF are an important cause for the experienced disability of patients, respiratory symptoms, and decreases in lungfunction, which require antibiotic therapy at home or in the hospital. Therefore, prevention of exacerbations in CF is important. The aim of this study was to assess the predictive properties of inflammatory markers in exhaled breath for pulmonary exacerbations in children with CF. In addition the reliability of home monitor assessments of symptoms and lungfunction was investigated.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cystic Fibrosis Children Exhaled Breath Condensate Non-invasive Inflammatory Markers Volatile Organic Compounds Home Monitoring Quality of Life

Medical Language ↔ Plain English

Inclusion Criteria: * CF disease is defined as the combination of: 1. characteristic clinical features (persistent pulmonary symptoms, meconium ileus, failure to thrive, steatorrhoea); 2. and/or abnormal sweat test (Chloride \> 60mM); 3. and/or two CF mutations. Exclusion Criteria: 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.

Locations (3)

Academic Medical Centre

Amsterdam, Netherlands

Maastricht University Medical Centre

Maastricht, Netherlands

University Medical Centre

Utrecht, Netherlands

Outcomes

Primary Outcomes

Number of exacerbations

Definition of an exacerbation according to Treggiari MM et al.

Time frame: 1 year

Secondary Outcomes

Quality of life

Quality of life questionnaire