Measurements of pulmonary function in children aged 0 - 4 years: children with CF and healthy controls.
- Conditions
- 10038716Cystic Fibrosis (CF)
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
Children with CF:
- Age 0-4 years; (0 years up to and including 4 years)
- Diagnosis of CF confirmed by sweat-test and/or DNA analysis and/or electro physiology testing (nasal potential difference measurement or intestinal current measurement);
- Clinically stable patients: no hospital admission and no need for an antibiotic course for at least 4 weeks prior to enrolment in the study;
- No signs of (viral) respiratory infection in the period from 1 week (7 days) before the measurement until the day of the measurement. (Viral) respiratory infection is defined as a combination of the following symptoms: rhinitis; pharyngitis; cough; headache; fever;
- Signed written informed consent.;Healthy controls:
- Age 0-4 years;
- No use of an antibiotic course (for pulmonary reasons) for at least 4 weeks prior to enrolment in the study;
- No signs of respiratory infection in the period from 1 week (7 days) before the measurement until the day of the measurement (definition of viral infection see children with CF);
- Signed written informed consent.
All study participants:
- Medical conditions that might affect the measurements (e.g. cardiac problems that can influence saturation, BPD (bronchopulmonary dysplasia)) that can influence LCI, etc.).;Children with CF:
- Pulmonary exacerbation at the time of the study.;Healthy controls:
- History of pulmonary diseases such as asthma, BPD, airway malacia;
- Current use of pulmonary drugs;
- History of premature birth (before 37 weeks gestation);
- ENT related interventions in recent history (< 1 month), such as tonsillectomy, antibiotics for ENT infections, grommets, etc.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Gas mixing measured by the Exhalyzer®D.<br /><br>- Nightly oxygen saturation measured by the Novametrix Model 2001 MARS pulse<br /><br>oximeter.<br /><br>- Nightly cough measured with an audio meter.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Differences between healthy children and children with CF.<br /><br>- Feasability (% successfully performed measurements) of the measurements. </p><br>