Zie pagina 14 research protocol
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Zie pagina 15 research protocol
Secondary outcome
Zie pagina 15 research protocol
Background summary
zie pagina 12-13 research protocol
Study objective
Zie pagina 14 research protocol
Study design
Zie pagina 14 research protocol
Study burden and risks
Zie pagina 23-24 research protocol
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Pediatric volunteers with cystic fibrosis age 8-18 years
Healthy pediatric volunteers age between 8 and 18 years
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- (History of)(passive) smoking, exclusion will take place when a subject has smoked in the last year, or has a smoking history of > 0.5 pack year (including e-cigarette, water pipe and smoking of cannabis). According to the validated definition of the Dutch PYAMA study passive smoking is defined as exposure in the household or in another indoor setting more than 2 times a week.
- (History of) cardiac disease
- History of premature birth before 36 weeks of gestational age
- Pregnant women, who are visually pregnant as judged by the investigator. The tests are harmless for the pregnant woman and the unborn child. However, due to pressure to the diaphragm the lung function can change.
- Fever, common cold or respiratory tract infection < 3 weeks before visit, as judged by the investigator;Control specific exclusion criteria:
- Abnormal spirometry defined as < 80% FEV1 or < -1.64 SD 30
- (History of) chronic or severe lung disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL63208.042.17 |