- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02890797
Assessment of Thoracic Echography for Pleuroparenchymatous Anomaly Diagnosis Complicating Bronchiolitis: BronchioIUS (BronchioIUS)
Evaluation of Thoracic Echography for Pleuroparenchymatous Anomaly Diagnosis Complicating Bronchiolitis: BronchioIUS
Study Overview
Detailed Description
900 to 1000 children are admitted each year for bronchiolitis in the pediatric emergency department of the Toulouse Children Hospital. The diagnosis is based on clinical examination, but in some cases furthers examinations such as chest X-ray are necessary in order to look for a parenchymal condensation. Even if French recommendations do not place chest ultrasound in the care pathway to date, many recent studies show the usefulness, rapidity and reliability of ultrasound in parenchymal abnormalities. But regarding the bronchiolitis, few studies are available and including limited numbers of patients. In addition, the reduction of irradiation is a main goal, especially in children.
We propose to performed a chest ultrasound in infants (<24 months) admitted for bronchiolitis with an available chest X-ray, in order to compare the performance of both examinations (X-ray and ultrasound) for the diagnosis of parenchymal condensation. Besides, to correlate initial chest ultrasound results and clinical evolution, parents will be contacted by phone 1 month after inclusion.
Primary outcome: The primary outcome is the sensitivity and specificity values of chest ultrasound for the diagnosis of parenchymal condensations diagnosed by chest X-ray. Positive and negative predictive values will also be estimated. This outcome is evaluated at the first visit (T0).
Secondary outcomes:
- To describe chest X-ray and ultrasound abnormalities in bronchiolitis.
- To evaluate the performance of chest ultrasound to distinguish retractile and non-retractile opacities complicating bronchiolitis.
- To study the correlation between clinical evolution at 1-month (malaise, place and duration of hospitalization, re-hospitalization, oxygen therapy, antibiotic therapy) and chest ultrasound results.
Follow-up parameters are recorded during a telephone call 1 month after inclusion.
Study design : It is a longitudinal, monocentric and prospective study with the aim to evaluate a diagnostic examination.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Toulouse, France, 31059
- Hôpital des Enfants, Unité de pneumo-allergologie pédiatrique
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Two years old patient at emergency Hospital (CHU-Toulouse) for bronchiolitis and performing of thoracic radiology
- Informed consent formed to sign by family before the exam and the evidence of social security regime affiliation.
Exclusion Criteria:
- Patient with cardiopulmonary disease or underlying immunosuppression
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Bronchiolitis children
Under two years old patient with bronchiolitis will have thoracic radiology
|
The investigators propose to performed a chest ultrasound in infants (<24 months) admitted for bronchiolitis with an available chest X-ray
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of parenchymatous opacity
Time Frame: Inclusion
|
Presence of parenchymatous opacity during thoracic radiological exam
|
Inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiological anomaly
Time Frame: Inclusion
|
Description of all pleuropulmonary anomaly in every radiological anomaly
|
Inclusion
|
Parenchymatous retractable (or non retractable) opacity
Time Frame: Inclusion
|
Assessment of radiographic capacity to differentiate Parenchymatous retractable (or non retractable) opacity
|
Inclusion
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/15/7858
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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