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Assessment of Thoracic Echography for Pleuroparenchymatous Anomaly Diagnosis Complicating Bronchiolitis: BronchioIUS (BronchioIUS)

Primary Purpose

Bronchiolitis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
radiology
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bronchiolitis focused on measuring bronchiolitis, parenchymal condensation, chest X-ray, chest ultrasound

Eligibility Criteria

undefined - 2 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital des Enfants, Unité de pneumo-allergologie pédiatrique

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Bronchiolitis children

Arm Description

Under two years old patient with bronchiolitis will have thoracic radiology

Outcomes

Primary Outcome Measures

Presence of parenchymatous opacity
Presence of parenchymatous opacity during thoracic radiological exam

Secondary Outcome Measures

Radiological anomaly
Description of all pleuropulmonary anomaly in every radiological anomaly
Parenchymatous retractable (or non retractable) opacity
Assessment of radiographic capacity to differentiate Parenchymatous retractable (or non retractable) opacity

Full Information

First Posted
July 12, 2016
Last Updated
December 7, 2021
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02890797
Brief Title
Assessment of Thoracic Echography for Pleuroparenchymatous Anomaly Diagnosis Complicating Bronchiolitis: BronchioIUS
Acronym
BronchioIUS
Official Title
Evaluation of Thoracic Echography for Pleuroparenchymatous Anomaly Diagnosis Complicating Bronchiolitis: BronchioIUS
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
The inclusions have been suspended from 03/18/2020 during the confinement period. In the meantime, a publication has appeared showing that the chest ultrasound has entered the common practice in the management of bronchiolitis.
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
February 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The diagnosis of bronchiolitis, the most frequent lung infectious disease in infancy, is based on clinical examination. Chest X-ray is proposed when a lung parenchymal condensation is suspected. Chest ultrasound is supposed to be a useful tool in the diagnosis of these complication but is poorly evaluated. We aim to compare chest X-ray and chest ultrasound for the diagnosis of parenchymal condensation in infant with bronchiolitis.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
bronchiolitis, parenchymal condensation, chest X-ray, chest ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bronchiolitis children
Arm Type
Other
Arm Description
Under two years old patient with bronchiolitis will have thoracic radiology
Intervention Type
Radiation
Intervention Name(s)
radiology
Intervention Description
The investigators propose to performed a chest ultrasound in infants (<24 months) admitted for bronchiolitis with an available chest X-ray
Primary Outcome Measure Information:
Title
Presence of parenchymatous opacity
Description
Presence of parenchymatous opacity during thoracic radiological exam
Time Frame
Inclusion
Secondary Outcome Measure Information:
Title
Radiological anomaly
Description
Description of all pleuropulmonary anomaly in every radiological anomaly
Time Frame
Inclusion
Title
Parenchymatous retractable (or non retractable) opacity
Description
Assessment of radiographic capacity to differentiate Parenchymatous retractable (or non retractable) opacity
Time Frame
Inclusion

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marine MICHELET, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital des Enfants, Unité de pneumo-allergologie pédiatrique
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessment of Thoracic Echography for Pleuroparenchymatous Anomaly Diagnosis Complicating Bronchiolitis: BronchioIUS

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