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

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.

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Key information

Conditions

Congenital Diaphragmatic Hernia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Diaphragmatic Hernias, Diaphragmatic, Congenital Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Primary Outcome Measure

Time frame: 2023-2025

Primary outcome of this study was HRQoL, assessed using the KIDSCREEN-27 questionnaire . It consists of 27 items covering 5 dimensions (Physical and Psychological Well-Being, Autonomy & Parent Relations, Social Support & Peers, and School Environment). Raw scores are transformed into T-scores with a mean of 50 and a standard deviation of 10 based on European normative data. Higher scores indicate better HRQoL. Self- and proxy-reported HRQoL were compared among CDH patients, parents, and siblings.

Statistical analyses were performed using SPSS©(V 29.0.2.0), Microsoft Excel© (V16.98), and R (V 4.4.2). Two-sided p-values <0.05 were considered statistically significant. Continuous variables are presented as mean±standard deviation or median (range), and categorical variables as percentages, based on the number of valid observations (N valid). Group comparisons were conducted using the chi-square test for categorical variables and the two-tailed unpaired t-test for continuous variables.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Feb 25, 2026
Registry last updated: Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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