BronchiolitisECHOPENCT04935996
A Study Pilot About the Contribution of Pleuropulmonary Echography Iin Acute Bronchiolitis Among Infants
A study testing Pleuropulmonary echography in people with Bronchiolitis, run by Centre Hospitalier Universitaire de Besancon.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Pleuropulmonary echography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Bronchiolitis
- Being tested
- Pleuropulmonary echography
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleuropulmonary echographyDevice
Pleuropulmonary echography is performed, in addition of the chest X-ray already performed in routine care
| Study group | Role | What they receive |
|---|---|---|
| Pleuropulmonary echography | Experimental | Not described Receives: Device: Pleuropulmonary echography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study startJun 2021 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien BEHR, MD, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935996
- Sponsor's protocol ID
- 2021/579
- Acronym
- ECHOPE
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Pilot About the Contribution of Pleuropulmonary Echography Iin Acute Bronchiolitis Among Infants
- ClinicalTrials.gov ID
- NCT04935996
- Acronym / sponsor ID
- ECHOPE / 2021/579
- Conditions
- Bronchiolitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pleuropulmonary echography | Experimental | Device: Pleuropulmonary echography |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pleuropulmonary echographyPleuropulmonary echography is performed, in addition of the chest X-ray already performed in routine care | Device | Pleuropulmonary echography |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien BEHR, MD principal investigator
CHU de Besançon
Questions about this trial
What is this clinical trial studying?
A study testing Pleuropulmonary echography in people with Bronchiolitis, run by Centre Hospitalier Universitaire de Besancon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien BEHR, MD (0033381667400, jbehr@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between PleuroPulmonary Echography [PPE] and pulmonary radiography (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.