Growing up after surgery for congenital diaphragmatic hernia (CDH): Problems for life? A study to evaluate optimal medical and psychosocial care in CDH 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 up till adulthood (CDH-FU) - Physical and psychosocial evaluation in adults born with CDH

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49276

Enrollment

Registered

2019-01-11

Start date

2020-05-13

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Congenital diafragmatic hernia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

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

Measure	Time 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) * Reduced maximal exercise capacity (VO2max) * Abnormal pulmonary structure on chest CT (separate volume fractions of total airways disease (%Dis), and trapped air (%TA))	—

Measure

Time 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) * Reduced maximal exercise capacity (VO2max) * Abnormal pulmonary structure on chest CT (separate volume fractions of total airways disease (%Dis), and trapped air (%TA))

—

Secondary

Measure	Time frame
* 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)	—

Measure

Time frame

* 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)

—

Countries

Netherlands

Outcome results