Children With Congenital Diaphragmatic Hernia and the Quality of Their Daily Lives (NCT07432672) | Clinical Trial Compass
CompletedNot Applicable
Children With Congenital Diaphragmatic Hernia and the Quality of Their Daily Lives
Austria80 participantsStarted 2023-05-01
Plain-language summary
Background: Congenital diaphragmatic hernia is a rare disease, resulting from a developmental malformation of the diaphragm. Over the last years, management of the affected children has improved significantly. Despite progress in the treatment, it is still related to a high mortality rate. After birth, congenital diaphragmatic hernias are associated with lung hypoplasia as well as pulmonary hypertension which can in turn lead to cardiac dysfunction. Comorbidities as gastroesophageal reflux or respiratory difficulties, such as chronic pulmonary symptoms or repeated respiratory tract infections are common amongst survivors. However, little is known about the health-related quality of life in children after surgical intervention of their diaphragm.
Aim: This study aims to obtain information on the health-related quality of life in children with congenital diaphragmatic hernia to improve their future long-term management.
Methods: A single-centre prospective study was conducted, examining health-related quality of life of children between five and 18 years of age who were initially treated at the General Hospital of Vienna for congenital diaphragmatic hernia between 2005 and 2019. The validated KIDSCREEN-27 questionnaire was used to assess the health-related quality of life of children with a congenital diaphragmatic hernia, completed by the whole family, including the affected child himself (≥ 8 years old), parents, and siblings. Additionally, a detailed demographic review was obtained.
Who can participate
Age range
5 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* In this study, patients diagnosed with CDH, born between 2005 and 2019 and treated at the Medical University of Vienna at the Comprehensive Center for Pediatrics were included after giving their written consent for this study. Children with CDH, at least eight years old, their parents, and siblings (eight years or older) were asked to complete the questionnaire.
* CDH patients answered the KIDSCREEN-27 childrens version questionnaire (see Appendix) if they were aged eight to 18 years.
* Parents answered the KIDSCREEN-27 parents version questionnaire (see Appendix). If the CDH patients were younger than eight years, only their parents were asked to fill out the questionnaire.
* If siblings were at least eight years old, they were also asked to complete a questionnaire, which is a newly created version of the KIDSCREEN-27 parents version concerning the quality of life of their CDH affected siblings (see Appendix).
Exclusion Criteria:
* Missing written informed consent to the study from the CDH patient, parents, or siblings led to exclusion. Parents and siblings of deceased patients were not included.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.