Growing up after surgery for Congenital Diaphragmatic Hernia (CDH): Problems for life? A study to evaluate optimal medical and psychosocial care in CDH Follow-Up till adulthood (CDH-FU)
Recruiting
- Conditions
- CHD at birth
- Registration Number
- NL-OMON29669
- Lead Sponsor
- ErasmusMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
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)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduced maximal exercise capacity (VO2max)
- Secondary Outcome Measures
Name Time Method Persistent pulmonary morbidity as reflected by:<br>? Irreversible small airway obstruction (FEV1 before and after bronchodilation, FEF25-75 before and after bronchodilatation)<br>? Reduced diffusion capacity of the lungs after correction for total lung capacity (DLOCc, KCORCL)<br>? Abnormal pulmonary structure on chest CT (separate volume fractions of total airways disease (%Dis), and trapped air (%TA))<br>? Abnormal morphology of the repaired diaphragm<br>? Echocardiographic signs of pulmonary hypertension and ventricular dysfunction4<br>? Total and subdomain scores participation (IPA)<br>? Health status (physical and mental scale of RAND-36)<br>? Total score fatigue (FSS)<br>? Dyspnea score<br>? Total score and domain scores social emotional wellbeing (scores on ASR)<br>? Airway artery (AA) dimensions using the AA-method<br>? Growth and nutritional status (BOD-POD)