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

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ClinicalTrials.gov Identifier: NCT02890797
Recruitment Status : Not yet recruiting
First Posted : September 7, 2016
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Radiation: radiology Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 143 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound X-Rays
Drug Information available for: X-Rays

Arm Intervention/treatment
Bronchiolitis children
Under two years old patient with bronchiolitis will have thoracic radiology
Radiation: radiology
The investigators propose to performed a chest ultrasound in infants (<24 months) admitted for bronchiolitis with an available chest X-ray




Primary Outcome Measures :
  1. Presence of parenchymatous opacity [ Time Frame: Inclusion ]
    Presence of parenchymatous opacity during thoracic radiological exam


Secondary Outcome Measures :
  1. Radiological anomaly [ Time Frame: Inclusion ]
    Description of all pleuropulmonary anomaly in every radiological anomaly

  2. Parenchymatous retractable (or non retractable) opacity [ Time Frame: Inclusion ]
    Assessment of radiographic capacity to differentiate Parenchymatous retractable (or non retractable) opacity



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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Marine Michelet, MD/PHD 05 34 55 75 39 ext 33 michelet.m@chu-toulouse.fr
Contact: Audrey Tomasik 05 61 77 85 97 tomasik.a@chu-toulouse.fr

Locations
France
Hôpital des Enfants, Unité de pneumo-allergologie pédiatrique Not yet recruiting
Toulouse, France, 31059
Contact: SYLVAIN BLANCHON, MD/PHD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Marine MICHELET, MD University Hospital, Toulouse

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02890797     History of Changes
Other Study ID Numbers: RC31/15/7858
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
bronchiolitis
parenchymal condensation
chest X-ray
chest ultrasound

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections