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

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Terminated

CT.gov ID

NCT02890797

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis	Radiation: radiology	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

N/A

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

Actual Study Start Date :

Jul 12, 2018

Actual Primary Completion Date :

Feb 10, 2020

Actual Study Completion Date :

Feb 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Arm

Intervention/Treatment

Other: 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

Outcome Measures

Primary Outcome Measures

Presence of parenchymatous opacity [Inclusion]
Presence of parenchymatous opacity during thoracic radiological exam

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 2 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital des Enfants, Unité de pneumo-allergologie pédiatrique	Toulouse		France	31059

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

Principal Investigator: Marine MICHELET, MD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Toulouse

ClinicalTrials.gov Identifier:

NCT02890797

Other Study ID Numbers:

RC31/15/7858

First Posted:

Sep 7, 2016

Last Update Posted:

Dec 29, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Toulouse

bronchiolitis

parenchymal condensation

chest X-ray

chest ultrasound

Additional relevant MeSH terms:

Bronchiolitis

Study Results

No Results Posted as of Dec 29, 2021