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Clinical Trials in France / NCT05500833
Recruiting Observational

Multidimensional Characterization of Dyspnea in Children

NCT05500833 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Observational
Started
2023-01-26
Last updated
2025-12-09

Condition(s) studied

Dyspnea and Respiratory Insufficiency in Children

Investigational drug(s) / intervention(s)

Multidimentional observation scale (MDP)

Multidimentional observation scale (MDP): Upon arriving to the hospital (for an hospitalization or a consultation), a trained and declared investigator will inform the patients and their parents of the study, orally and using a written information note. Participation to the study will also be proposed to under aged children in an adequate language and a specific information note will be handed to them. If they wish, they will have a 20 min reflexion time before deciding on participating to the study.One the patient is included, the study will unfold as follows. First, Evaluation of acute dyspnea: general data and dyspnea scores will be collected upon inclusion, and dyspnea score will be collected once again 30 min later, and subsequently one a day until the end of hospitalization (test-retest). Data from clinical examination and treatment modifications will also be collected daily. Second, Evaluation of chronic dyspnea: general data and dyspnea scores will be collected upon inclusion and 1 to 1.5h later

Study summary

There is no specific tool existing to describe dyspnea in children in a multidimensional way.

It has been shown in adult studies that multidimensional dyspnea evaluation scales are well correlated to quality of life and respiratory function impairments.

The investigators hypothesis is that using multidimensional dyspnea evaluation scales could allow for a more systematic and precise evaluation of this symptom in children, thus improving management and follow-up of patients presenting with acute (asthma attack, infectious diseases) and chronic (cystic fibrosis, primary ciliary diskynesia, neuromuscular diseases) respiratory insufficiency.

Eligibility

Sex
ALL
Min age
6 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Children aged between 6-17 years old at inclusion * Experiencing respiratory complaints at inclusion * Social security number * Children whom parents or legal representatives are present or reachable via phone call at inclusion * Non-opposition of parents or legal representatives to participate in the study * Children who are followed at or hospitalized in Trousseau hospital's pediatric pulmonology department for: asthma attack, acute respiratory insufficiency, acute exacerbation of a chronic respiratory disease, chronic respiratory insufficiency. * For the study of acute dyspnea: patients hospitalized for acute respiratory disease since less than 72h. * For the study of chronic dyspnea: children presenting with chronic respiratory disease. Exclusion Criteria: * Cognitive disorders making it impossible to understand self-assessment scales * Refusal of the child to participate in the research For the assessment of chronic dyspnea: * Children followed for a chronic respiratory pathology having presented an episode of acute respiratory decompensation in the 6 weeks preceding inclusion.

Primary outcome measure(s)

  • Validate the Multidimensional Dyspnea Profale (MDP) self-evaluation scale in children aged between 12 and 17 years presenting with acute or chronic dyspnea. — through study completion, an average of 36 months
    Use of the MDP questionnaire and test if usable and compliant for the teenager. (Scale from 0 to 10, with 10 corresponding to significant breathing difficulties.)

Trial sites (1)

FacilityCityRegionStatus
Service de pneumologie pédiatrique, Hôpital Armand Trousseau Paris France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05500833 on ClinicalTrials.gov ↗ ← All trials in France