Infectious and Non-infectious Lower Respiratory Diseases in Children With Down Syndrome Followed in Pediatric Pulmonology Consultations in Ile-de-France (ARBT21)

August 14, 2024 updated by: Centre Hospitalier Sud Francilien
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Corbeil-Essonnes, France, 91106
        • Centre Hospitalier Sud Francilien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

children with Down syndrome, who were hospitalized for respiratory problems and who had subsequent pediatric pulmonology follow-up between 2013 and 2023

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
distribution of lower respiratory tract diseases
Time Frame: at day 0
number
at day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Sud Francilien

Investigators

  • Principal Investigator: Yousra MESBAHI, MD, C

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2024

Primary Completion (Actual)

June 26, 2024

Study Completion (Actual)

June 26, 2024

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 14, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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