NL-OMON31363
Completed
Not Applicable
Measurements of pulmonary function in children aged 0 - 4 years: children with CF and healthy controls. - FLY: Function measurements of the Lungs in Young children
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cystic Fibrosis (CF)
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 45
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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