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

June 15, 2021 updated by: Centre Hospitalier Universitaire de Besancon

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pleuropulmonary echography
Device: Pleuropulmonary echography
Pleuropulmonary echography is performed, in addition of the chest X-ray already performed in routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between PleuroPulmonary Echography [PPE] and pulmonary radiography
Time Frame: Day 1
Comparative analysis between PPE and chest/pulmonary radiography (gold standard) for the diagnosis of bacterial pneumonitis associated with acute bronchiolitis in infants.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Julien BEHR, MD, CHU de Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

June 23, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/579

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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