BronchiolitisBronchioIUSNCT02890797
Assessment of Thoracic Echography for Pleuroparenchymatous Anomaly Diagnosis Complicating Bronchiolitis: BronchioIUS
A study testing radiology in people with Bronchiolitis, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- radiology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2018to 10 Feb 2020
- 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
- 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.
Who cannot join
- Patient with cardiopulmonary disease or underlying immunosuppression
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital des Enfants, Unité de pneumo-allergologie pédiatrique
Toulouse, 31059
About this study
Official title: Evaluation of Thoracic Echography for Pleuroparenchymatous Anomaly Diagnosis Complicating Bronchiolitis: BronchioIUS
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.
Read the 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.
- Conditions
- Bronchiolitis
- Being tested
- radiology
- Keywords
- bronchiolitis, parenchymal condensation, chest X-ray, chest ultrasound
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiologyRadiation
The investigators propose to performed a chest ultrasound in infants (<24 months) admitted for bronchiolitis with an available chest X-ray
| Study group | Role | What they receive |
|---|---|---|
| Bronchiolitis children | Other | Under two years old patient with bronchiolitis will have thoracic radiology Receives: Radiation: radiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of parenchymatous opacity
Presence of parenchymatous opacity during thoracic radiological exam
Measured: Inclusion
Secondary outcomes (2)
Radiological anomaly
Description of all pleuropulmonary anomaly in every radiological anomaly
Measured: Inclusion
Parenchymatous retractable (or non retractable) opacity
Assessment of radiographic capacity to differentiate Parenchymatous retractable (or non retractable) opacity
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start12 Jul 2018
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Why it stopped: The inclusions have been suspended from 03/18/2020 during the confinement period. In the meantime, a publication has appeared showing that the chest ultrasound has entered the common practice in the management of bronchiolitis.
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 University Hospital, ToulouseThe 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marine MICHELET, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890797
- Sponsor's protocol ID
- RC31/15/7858
- Acronym
- BronchioIUS
- Status last verified
- May 2026
- First submitted
- 12 Jul 2016
- Last updated
- 29 May 2026
- 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thoracic Echography for Pleuroparenchymatous Anomaly Diagnosis Complicating Bronchiolitis: BronchioIUS
- ClinicalTrials.gov ID
- NCT02890797
- Acronym / sponsor ID
- BronchioIUS / RC31/15/7858
- Conditions
- Bronchiolitis
- Keywords
- bronchiolitis, parenchymal condensation, chest X-ray, chest ultrasound
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The inclusions have been suspended from 03/18/2020 during the confinement period. In the meantime, a publication has appeared showing that the chest ultrasound has entered the common practice in the management of bronchiolitis.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 7 Sep 2016 (estimated)
- 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.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchiolitis children | Other | Radiation: radiologyUnder two years old patient with bronchiolitis will have thoracic radiology |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient with cardiopulmonary disease or underlying immunosuppression
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 |
|---|---|---|
| radiologyThe investigators propose to performed a chest ultrasound in infants (<24 months) admitted for bronchiolitis with an available chest X-ray | Radiation | Bronchiolitis children |
Primary outcome
Presence of parenchymatous opacity
Time frame: Inclusion
Presence of parenchymatous opacity during thoracic radiological exam
2 secondary outcomes
Radiological anomaly
Time frame: Inclusion
Parenchymatous retractable (or non retractable) opacity
Time frame: Inclusion
Results and safety
The study was stopped early (reason given: The inclusions have been suspended from 03/18/2020 during the confinement period. In the meantime, a publication has appeared showing that the chest ultrasound has entered the common practice in the management of bronchiolitis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- 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.
Marine MICHELET, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiology in people with Bronchiolitis, run by University Hospital, Toulouse at 1 site in France.
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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: The inclusions have been suspended from 03/18/2020 during the confinement period. In the meantime, a publication has appeared showing that the chest ultrasound has entered the common practice in the management of bronchiolitis.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of parenchymatous opacity (time frame: Inclusion). 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 29 May 2026.