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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05527873
Other study ID # 8562
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 16, 2022
Est. completion date December 16, 2022

Study information

Verified date November 2023
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The respiratory complications of esophageal atresia have already been identified. They are mainly related to tracheomalacia linked to the esophageal malformation, and are aggravated by frequently associated gastroesophageal reflux. In this context, symptoms of asthma (or bronchial hyperreactivity) occur more frequently than in the general population and persist into adulthood. Their pathogenesis is still poorly understood and is the subject of much discussion. The therapeutic management of these respiratory complications, poorly codified, remains very heterogeneous from one center to another. In France, the summary of knowledge is updated by the Reference Center for chronic and malformative diseases of the esophagus.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date December 16, 2022
Est. primary completion date October 16, 2022
Accepts healthy volunteers
Gender All
Age group 1 Year to 12 Years
Eligibility Inclusion criteria: - Child aged 1 to 12 years old - Child operated on for esophageal atresia between 01/01/2010 and 31/12/2020 and followed up at the University Hospitals of Strasbourg - Child who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research - Parental authority having not expressed, after being informed, their opposition to the reuse of their child's data for the purposes of this research. Exclusion criteria: Subject and/or parental authority having expressed their opposition to participating in the study

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Centre de Ressources et de Compétences de la Mucoviscidose (CRCM) - CHU de Strasbourg - France Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retrospective study of respiratory complications of esophageal atresia in children Files analysed retrospectively from January 01, 2010 to December 31, 2020 will be examined
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