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Engagement in Physical Activities and Sports in Adolescents With Diaphragmatic Hernia

NCT ID: NCT05666986

Last Updated: 2022-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-31

Study Completion Date

2024-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Diaphragmatic Hernia

Keywords

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CDH physical activity and sports childhood and adolescence environment sociological psychological clinical

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Parents or child/adolescent not understanding French
* Parents under guardianship or child under legal protection
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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APEHDia, a french CDH patient association

UNKNOWN

Sponsor Role collaborator

Rare Disease Foundation, France

UNKNOWN

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sébastien MUR, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Central Contacts

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Sébastien MUR, MD

Role: CONTACT

Phone: 0320445962

Email: [email protected]

Other Identifiers

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2021-A02518-33

Identifier Type: OTHER

Identifier Source: secondary_id

2021_0342

Identifier Type: -

Identifier Source: org_study_id