Assessment of Thoracic Echography for Pleuroparenchymatous Anomaly Diagnosis Complicating Bronchiolitis: BronchioIUS (BronchioIUS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02890797|
Recruitment Status : Not yet recruiting
First Posted : September 7, 2016
Last Update Posted : June 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis||Radiation: radiology||Not Applicable|
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).
- 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||143 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Thoracic Echography for Pleuroparenchymatous Anomaly Diagnosis Complicating Bronchiolitis: BronchioIUS|
|Estimated Study Start Date :||September 2018|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
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
- Presence of parenchymatous opacity [ Time Frame: Inclusion ]Presence of parenchymatous opacity during thoracic radiological exam
- Radiological anomaly [ Time Frame: Inclusion ]Description of all pleuropulmonary anomaly in every radiological anomaly
- Parenchymatous retractable (or non retractable) opacity [ Time Frame: Inclusion ]Assessment of radiographic capacity to differentiate Parenchymatous retractable (or non retractable) opacity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890797
|Contact: Marine Michelet, MD/PHD||05 34 55 75 39 ext email@example.com|
|Contact: Audrey Tomasik||05 61 77 85 firstname.lastname@example.org|
|Hôpital des Enfants, Unité de pneumo-allergologie pédiatrique||Not yet recruiting|
|Toulouse, France, 31059|
|Contact: SYLVAIN BLANCHON, MD/PHD|
|Principal Investigator:||Marine MICHELET, MD||University Hospital, Toulouse|