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ID
Source
Brief title
Health condition
CHD at birth
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reduced maximal exercise capacity (VO2max)
Secondary outcome
Persistent pulmonary morbidity as reflected by:
Irreversible small airway obstruction (FEV1 before and after bronchodilation, FEF25-75 before and after bronchodilatation)
Reduced diffusion capacity of the lungs after correction for total lung capacity (DLOCc, KCORCL)
Abnormal pulmonary structure on chest CT (separate volume fractions of total airways disease (%Dis), and trapped air (%TA))
Abnormal morphology of the repaired diaphragm
Echocardiographic signs of pulmonary hypertension and ventricular dysfunction4
Total and subdomain scores participation (IPA)
Health status (physical and mental scale of RAND-36)
Total score fatigue (FSS)
Dyspnea score
Total score and domain scores social emotional wellbeing (scores on ASR)
Airway artery (AA) dimensions using the AA-method
Growth and nutritional status (BOD-POD)
Background summary
To evaluate persisting pulmonary morbidity and echocardiographic signs of pulmonary hypertension in young adults born with CDH that interfere with physical fitness and participation in society.
Secondary Objective(s): To evaluate fatigue, social-emotional wellbeing, nutritional and health status, and participation in society.
Study objective
to improve the medical care on long term follow up
Study design
1 study day for all the test, 1 meeting for discuss the results
Intervention
ECG, BOD-POD, lung-functiontest, questionnaires, CT and physical examination
Inclusion criteria
Diagnosed with CDH within the first 7 days of life and alive at time of recruitment
Born between 1989 and 2001 (patient recruitment is ongoing in 2019; minimum age is 18 years)
Sufficient intellectual capacities and/or command of the Dutch language to understand instructions
Clinically stable for > 3 weeks
Exclusion criteria
Serious comorbidity that might affect assessments (e.g. serious neurological comorbidity)
Design
Recruitment
IPD sharing statement
Plan description
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 |
|---|---|
| NTR-new | NL7688 |
| Other | METC Erasmus MC : METC 2018-1588 |