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A Study Pilot About the Contribution of Pleuropulmonary Echography Iin Acute Bronchiolitis Among Infants (ECHOPE)

Primary Purpose

Bronchiolitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pleuropulmonary echography
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bronchiolitis

Eligibility Criteria

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

Inclusion Criteria:

  • Infants aged <= 2 years old
  • Medical diagnosis of acute bronchiolitis requiring hospitalization in the pediatric departments of the Besançon University Hospital
  • No opposition from the parents for performing the pleuropulmonary echography.

Exclusion Criteria:

  • Children aged > 2 years old
  • Infants aged < 2 years old consultant in pediatric emergencies for acute bronchiolitis without subsequent hospitalization.
  • Previous chronic lung disease (including pulmonary bronchodysplasia), unoperated congenital heart disease or neuromuscular disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Pleuropulmonary echography

    Arm Description

    Outcomes

    Primary Outcome Measures

    Comparison between PleuroPulmonary Echography [PPE] and pulmonary radiography
    Comparative analysis between PPE and chest/pulmonary radiography (gold standard) for the diagnosis of bacterial pneumonitis associated with acute bronchiolitis in infants.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 15, 2021
    Last Updated
    June 15, 2021
    Sponsor
    Centre Hospitalier Universitaire de Besancon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04935996
    Brief Title
    A Study Pilot About the Contribution of Pleuropulmonary Echography Iin Acute Bronchiolitis Among Infants
    Acronym
    ECHOPE
    Official Title
    A Study Pilot About the Contribution of Pleuropulmonary Echography Iin Acute Bronchiolitis Among Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2021 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon

    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
    Pleuropulmonary echography remains an almost non-existent tool in routine pediatric practice. Our study is part of a desire to develop its use in pediatrics, in particular for the diagnosis of acute bacterial pneumonitis associated with acute bronchiolitis among infants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchiolitis

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Pleuropulmonary echography
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Pleuropulmonary echography
    Intervention Description
    Pleuropulmonary echography is performed, in addition of the chest X-ray already performed in routine care
    Primary Outcome Measure Information:
    Title
    Comparison between PleuroPulmonary Echography [PPE] and pulmonary radiography
    Description
    Comparative analysis between PPE and chest/pulmonary radiography (gold standard) for the diagnosis of bacterial pneumonitis associated with acute bronchiolitis in infants.
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    2 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Infants aged <= 2 years old Medical diagnosis of acute bronchiolitis requiring hospitalization in the pediatric departments of the Besançon University Hospital No opposition from the parents for performing the pleuropulmonary echography. Exclusion Criteria: Children aged > 2 years old Infants aged < 2 years old consultant in pediatric emergencies for acute bronchiolitis without subsequent hospitalization. Previous chronic lung disease (including pulmonary bronchodysplasia), unoperated congenital heart disease or neuromuscular disease.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Julien BEHR, MD
    Phone
    0033381667400
    Email
    jbehr@chu-besancon.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Julien BEHR, MD
    Organizational Affiliation
    CHU de Besançon
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Study Pilot About the Contribution of Pleuropulmonary Echography Iin Acute Bronchiolitis Among Infants

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