NCT06336577

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

March 28, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2024

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

March 22, 2024

Last Update Submit

August 14, 2024

Conditions

Down Syndrome

Keywords

Down syndromechildrenlower respiratory diseasesrespiratory infectionrespiratory syncytial virushemosiderosisasthmabronchiolitis

Outcome Measures

Primary Outcomes (1)

  • distribution of lower respiratory tract diseases

    number

    at day 0

Interventions

lower respiratory tract diseaseOTHER

lower respiratory tract disease

Eligibility Criteria

Age1 Day - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Patient under guardianship or curators
  • Adult or holders of parental authority informed of the study and having objected to it

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

Location

MeSH Terms

Conditions

Down SyndromeRespiratory Tract InfectionsHemosiderosisAsthmaBronchiolitis

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornInfectionsRespiratory Tract DiseasesIron OverloadIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBronchial DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesBronchitis

Study Officials

  • Yousra MESBAHI, MD

    C

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2024

First Posted

March 28, 2024

Study Start

March 28, 2024

Primary Completion

June 26, 2024

Study Completion

June 26, 2024

Last Updated

August 15, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)