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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)

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)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON29669
Enrollment
50
Registered
2019-04-18
Start date
2019-04-18
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CHD at birth

Interventions

ECG, BOD-POD, lung-functiontest, questionnaires, CT and physical examination

Sponsors

ErasmusMC
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: ? Serious comorbidity that might affect assessments (e.g. serious neurological comorbidity)

Design outcomes

Primary

MeasureTime frame
Reduced maximal exercise capacity (VO2max)

Secondary

MeasureTime frame
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)

Contacts

Public ContactJoke Dunk

Erasmus MC

j.dunk@erasmusmc.nl0647634987

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)