NCT04935996

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

2 years

First QC Date

June 15, 2021

Last Update Submit

June 15, 2021

Conditions

Bronchiolitis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1

Study Arms (1)

Pleuropulmonary echography

EXPERIMENTAL
Device: Pleuropulmonary echography

Interventions

Pleuropulmonary echographyDEVICE

Pleuropulmonary echography is performed, in addition of the chest X-ray already performed in routine care

Pleuropulmonary echography

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Julien BEHR, MD

    CHU de Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien BEHR, MD

CONTACT

0033381667400jbehr@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2021

First Posted

June 23, 2021

Study Start

June 1, 2021

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

June 23, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share