NCT07432672

Children With Congenital Diaphragmatic Hernia and the Quality of Their Daily Lives

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Congenital Diaphragmatic Hernia

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2026-02-25
• Last updated: 2026-02-27

Locations

1 site across 1 country: Austria