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NCT06336577 Clinical Trial

Infectious and Non-infectious Lower Respiratory Diseases in Children With Down Syndrome Followed in Pediatric Pulmonology Consultations in Ile-de-France

Down Syndrome Clinical Trial

— ARBT21  

Official title:
Infectious and Non-infectious Lower Respiratory Diseases in Children With Down Syndrome Followed in Pediatric Pulmonology Consultations in Ile-de-France

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06336577
Other study ID # 2024/0003
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2024
Est. completion date December 31, 2024

Study information
Verified date March 2024
Source Centre Hospitalier Sud Francilien
Contact Yousra MESBAHI, MD
Phone 0161697760
Email yousra.mesbahi@chsf.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to describe infectious and non-infectious lower respiratory tract diseases in children with Down syndrome followed in pediatric pulmonology consultations in Ile de France.

Description:

Down syndrome is the most common chromosomal abnormality, affecting 600 to 800 births per year. It results in a clinical picture that combines developmental delay, mental deficiency, facial dysmorphism and visceral malformations. Optimal medical care of Down syndrome patients requires a good knowledge of the different systems affected by the disease, particularly respiratory damage. Numerous articles have been published describing upper respiratory problems in children with Down syndrome. On the other hand, lower respiratory problems causing significant morbidity and mortality remain underestimated and poorly understood in this population. The objective of this study is to describe lower respiratory problems in patients with T21, in order to improve their management. This study will also make it possible to describe more precisely the impact that these attacks have on Down syndrome patients. This study also describe the associated extra-respiratory disorders to improve overall care Finally, the respiratory care of these patients will be described, with the aim of standardizing practices.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 250
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers
Gender All
Age group 1 Day to 17 Years
Eligibility Inclusion Criteria: - Child from 0 to 17 years old - Carrier of Down syndrome confirmed by karyotype - Having had follow-up in a pediatric pulmonology consultation for an infectious or non-infectious lower respiratory tract - Not exclusively presenting upper respiratory otorhinolaryngological damage Exclusion Criteria: - Patient under guardianship or curators - Adult or holders of parental authority informed of the study and having objected to it

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• lower respiratory tract disease
lower respiratory tract disease

Locations
Country Name City State
France Centre Hospitalier Sud Francilien Corbeil-Essonnes

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary distribution of lower respiratory tract diseases number at day 0
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