Congenital Diaphragmatic HerniaCHASAMNCT05666986
Engagement in Physical Activities and Sports in Adolescents With Diaphragmatic Hernia
An observational study of Congenital Diaphragmatic Hernia, run by University Hospital, Lille at 1 site in France.
Trial summary
The objective is to understand how a population of adolescents - who have undergone diaphragm surgery within their first month of life (i.e. subjects who have been carriers of a rare impacting disease such as congenital diaphragmatic hernia (CDH)) - engages in physical and sports activities and what can be the… Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Diaphragmatic Hernia
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2022to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All adolescents who had CDH surgery in the first month of life, without any other pathology, now aged 12-18 and followed up at the CDH Lille Reference Center, will be asked to take part in the study.
Who may be able to join
- Child/adolescent having undergone surgery for CDH in the first month of life, aged 12 to 18 years; absence of polypathology (i.e. diaphragmatic hernia not associated with another pathology); follow-up at the CDH reference centre, Lille site
- Written consent from both parents allowing the collection of data from the child/adolescent
- Written consent from the parent(s) agreeing to participate in the study by answering the questionnaires and the individual interview, for themselves and for their child
- Possibility of accessing equipment to conduct a video-conference interview if necessary.
Who cannot join
- Parents or child/adolescent not understanding French
- Parents under guardianship or child under legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
chu de Lille
Lille
Sébastien MUR, 0033320445962, sebastien.mur@chu-lille.fr
About this study
Official title: Identification of Obstacles and Facilitators to the Engagement in Physical and Sports Activities in a Population of Adolescents Operated on for a Diaphragmatic Hernia
The objective is to understand how a population of adolescents - who have undergone diaphragm surgery within their first month of life (i.e. subjects who have been carriers of a rare impacting disease such as congenital diaphragmatic hernia (CDH)) - engages in physical and sports activities and what can be the hindering factors as well as the factors facilitating these practices.
Based on self-questionnaires and semi-structured interviews, this research is a qualitative research in the field of human and social sciences.
Read more
The qualitative survey will make it possible to report on the experience of the disease of children and parents; in parallel, a complete medical evaluation of the subjects (clinical and para-clinical) will be carried out.
The analysis of the verbatim of the self-questionnaires and interviews with regard to the real physical capacities of the subjects, will be discussed.
- Conditions
- Congenital Diaphragmatic Hernia
- Keywords
- CDH, physical activity and sports, childhood and adolescence, environment sociological, psychological clinical
- Medical subject headings
- Hernias, Diaphragmatic, Congenital, Motor Activity
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 |
|---|---|---|
| Adolescents who had CDH surgery in the first month of life, | without any other pathology, now aged 12-18 and followed up at the CDH Lille Reference Center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-questionnaire (for the subjects)
to collect the level of investment of the subject in their sport participation (from the subject's point of view)
Measured: At the time of inclusion
Self-questionnaire (for the subject's parents)
to collect the subject's level of involvement in their sport (from the subject's parents' point of view
Measured: At the time of inclusion
semi-directive interview of the subject
allowing the identification of the dynamics of involvement in physical activities and sports practices, from the point of view of the subject (the adolescent)
Measured: At the time of inclusion
semi-directive interview of the subject's parents
allowing the identification of the dynamics of involvement in physical activities and sports practices, from the point of view of the subject's parents
Measured: At the time of inclusion
Secondary outcomes (2)
study of the diaphragmatic kinetics by cardiac MRI
Complete clinical examination of the subjects and detailed paraclinical evaluation according to the recommendations of the PNDS with the addition of a sequence during the cardiac MRI allowing the study of the diaphragmatic kinetics.
Measured: At the time of inclusion
Self-questionnaire and interviews (for the subjects)
Analysis of the verbatim of the self-questionnaires and the interviews, with regard to the real physical capacities of the subjects.
Measured: At the time of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start19 May 2022
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
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 University Hospital, LilleThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- APEHDia, a french CDH patient association, Rare Disease Foundation, France
- Responsible party
- Sponsor
- Investigators
- Sébastien MUR, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666986
- Sponsor's protocol ID
- 2021_0342
- Other IDs
- 2021-A02518-33
- Acronym
- CHASAM
- Status last verified
- May 2026
- First submitted
- 15 Dec 2022
- Last updated
- 22 May 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Obstacles and Facilitators to the Engagement in Physical and Sports Activities in a Population of Adolescents Operated on for a Diaphragmatic Hernia
- ClinicalTrials.gov ID
- NCT05666986
- Acronym / sponsor ID
- CHASAM / 2021_0342
- Conditions
- Congenital Diaphragmatic Hernia
- Keywords
- CDH, physical activity and sports, childhood and adolescence, environment sociological, psychological clinical
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- APEHDia, a french CDH patient association, Rare Disease Foundation, France
- Study start
- 19 May 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Dec 2022 (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.
The objective is to understand how a population of adolescents - who have undergone diaphragm surgery within their first month of life (i.e. subjects who have been carriers of a rare impacting disease such as congenital diaphragmatic hernia (CDH)) - engages in physical and sports activities and what can be the hindering factors as well as the factors facilitating these practices.
Based on self-questionnaires and semi-structured interviews, this research is a qualitative research in the field of human and social sciences.
The qualitative survey will make it possible to report on the experience of the disease of children and parents; in parallel, a complete medical evaluation of the subjects (clinical and para-clinical) will be carried out.
The analysis of the verbatim of the self-questionnaires and interviews with regard to the real physical capacities of the subjects, will be discussed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents who had CDH surgery in the first month of life, | – | –without any other pathology, now aged 12-18 and followed up at the CDH Lille Reference Center |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All adolescents who had CDH surgery in the first month of life, without any other pathology, now aged 12-18 and followed up at the CDH Lille Reference Center, will be asked to take part in the study.
Key inclusion criteria (4 listed)
- Child/adolescent having undergone surgery for CDH in the first month of life, aged 12 to 18 years; absence of polypathology (i.e. diaphragmatic hernia not associated with another pathology); follow-up at the CDH reference centre, Lille site
- Written consent from both parents allowing the collection of data from the child/adolescent
- Written consent from the parent(s) agreeing to participate in the study by answering the questionnaires and the individual interview, for themselves and for their child
- Possibility of accessing equipment to conduct a video-conference interview if necessary.
Key exclusion criteria (2 listed)
- Parents or child/adolescent not understanding French
- Parents under guardianship or child under legal protection
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
Self-questionnaire (for the subjects)
Time frame: At the time of inclusion
to collect the level of investment of the subject in their sport participation (from the subject's point of view)
Self-questionnaire (for the subject's parents)
Time frame: At the time of inclusion
to collect the subject's level of involvement in their sport (from the subject's parents' point of view
semi-directive interview of the subject
Time frame: At the time of inclusion
allowing the identification of the dynamics of involvement in physical activities and sports practices, from the point of view of the subject (the adolescent)
semi-directive interview of the subject's parents
Time frame: At the time of inclusion
allowing the identification of the dynamics of involvement in physical activities and sports practices, from the point of view of the subject's parents
2 secondary outcomes
study of the diaphragmatic kinetics by cardiac MRI
Time frame: At the time of inclusion
Self-questionnaire and interviews (for the subjects)
Time frame: At the time of inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
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Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
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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.
Sébastien MUR, MD principal investigator
University Hospital, Lille
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 University Hospital, Lille at 1 site in France.
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 2 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: looking for participants now, as of the sponsor's last update on 22 May 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sébastien MUR, MD (0320445962 ext. +33, sebastien.mur@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-questionnaire (for the subjects) (time frame: At the time of inclusion). The study lists 4 primary outcomes in all. 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 22 May 2026.