Congenital Diaphragmatic HerniaNCT07432672
Children With Congenital Diaphragmatic Hernia and the Quality of Their Daily Lives
An observational study of Congenital Diaphragmatic Hernia, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Diaphragmatic Hernia
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2023to 1 Jul 2025
- How long will I take part?
- 14 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: General Hospital of Vienna
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Keywords
- Quality of life
- Medical subject headings
- Hernias, Diaphragmatic, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Child (CDH patients) | Not described | |
| Parents | Not described | |
| Siblings | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
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.
Measured: 2023-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 May 2023
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Diaphragmatic HerniaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 14 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Bettina Brandt; MD MSc, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432672
- Sponsor's protocol ID
- EK-Nr: 1244/2023
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children With Congenital Diaphragmatic Hernia and the Quality of Their Daily Lives
- ClinicalTrials.gov ID
- NCT07432672
- Acronym / sponsor ID
- EK-Nr: 1244/2023
- Conditions
- Congenital Diaphragmatic Hernia
- Keywords
- Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Child (CDH patients) | – | – |
| Parents | – | – |
| Siblings | – | – |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- General Hospital of Vienna
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Diaphragmatic Hernia, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: 2023-2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.