Bronchiolitis AcuteNCT03280732
Use of Lung Ultrasound in Children With Acute Bronchiolitis
A study testing Lung Ultrasound in people with Bronchiolitis Acute, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Bronchiolitis is the leading cause of hospitalization in infants. The diagnosis is clinical and chest x-ray (CXR) should be reserved for severe cases in which signs of pulmonary complications are present. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Bronchiolitis Acute
- What is being tested?
- Lung Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2016to Dec 2018
- 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 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children hospitalized with a diagnosis of bronchiolitis
- Age < 24 months
- CXR as part of usual clinical practice because of clinical suspicion of pulmonary complications
- Informed written consent
Who cannot join
- chronic respiratory disease (i.e. bronchopulmonary dysplasia)
- congenital heart disease
- severe neuromuscular disease
- congenital or acquired immunodeficiency
Trial locations and contacts
1 site in 1 country.
Italy1 site
Pediatric Emergency Unit, S. Orsola-Malpighi Hospital
Bologna, BO, 40138
About this study
Official title: Lung Ultrasound in Diagnosing and Monitoring of Pulmonary Complications in Children With Acute Bronchiolitis
Bronchiolitis is the leading cause of hospitalization in infants. The diagnosis is clinical and chest x-ray (CXR) should be reserved for severe cases in which signs of pulmonary complications are present. Nevertheless, CXR is performed in more than 50% of hospitalized patients with bronchiolitis, which exposes infants to ionizing radiation.
Data on the possible role of lung ultrasound (LUS) in children with bronchiolitis and suspected pulmonary complications have not been published yet.
Read more
The purpose of this study is to evaluate the use of LUS compared to CXR in diagnosing and monitoring pulmonary complications (pneumonia, pleural effusion, pneumothorax) in children with acute bronchiolitis. The second purpose of the study is to evaluate the correlation between clinical course and ultrasound findings in children with bronchiolitis.
The inclusion of LUS in the diagnostic work-up of bronchiolitis could possibly reduce the misuse of CXR in infants and the exposure to ionizing radiations.
Read the detailed description
Bronchiolitis is the most common lower respiratory tract infection that affects children younger than 24 months. The diagnosis is clinical and, according to international guidelines, chest x-ray (CXR) should be reserved for cases in which signs of pulmonary complications are present or where respiratory effort is severe to warrant intensive care unit admission. Despite these recommendations, CXR is still performed in about 50% of bronchiolitis (ranging from 24 to 77%), which exposes infants to ionizing radiation.
Given its portability, no ionizing radiation, rapid and repeat testing, lung ultrasound (LUS) has become an emerging diagnostic tool for pneumonia, pleural effusion and pneumothorax in adults and children. At present, LUS is not included in the diagnostic work-up of bronchiolitis. Previous papers have reported that LUS may be useful in bronchiolitis because of a good correlation between clinical course and ultrasound findings. However, data on the possible role of LUS in children with bronchiolitis and suspected pulmonary complications have not been published yet.
Enrolled patients will undergo a bedside LUS in the first 12 hours after CXR. LUS will be performed by one paediatrician with specific LUS expertise and blinded to clinical and radiological data. The paediatrician must have previously attended a specific course on LUS and supervised practical training. A Mindray-DC-T6 ultrasound machine equipped with a linear probe with frequencies ranging from 7.5 to 12 MHz will be use. LUS examination will consist of both longitudinal and transversal sections from the anterior, lateral and posterior chest wall according to the methodology described by Copetti et al. A radiologist will then independently repeat the LUS to test the sonographer inter-observer agreement. The radiologist will be blinded to the results of the previous studies (LUS and CXR). The LUS findings will be recorded on the data form together with patient demographics, symptoms, CXR findings and laboratory data.
Patients with LUS positive for pulmonary complications will receive follow-up ultrasound every 48 hours until the resolution or the discharge.
- Conditions
- Bronchiolitis Acute
- Being tested
- Lung Ultrasound
- Keywords
- Lung Ultrasound, Chest X-Ray, Pneumonia, Pneumothorax, Pleural effusion
- Medical subject headings
- Pneumonia, Pneumothorax, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung UltrasoundDevice
A Mindray-DC-T6 ultrasound machine equipped with a linear probe with frequencies ranging from 7.5 to 12 MHz will be use. LUS examination will consist of both longitudinal and transversal sections according to the methodology described by Copetti and colleagues.
| Study group | Role | What they receive |
|---|---|---|
| Lung Ultrasound | Experimental | Bedside lung ultrasound will be performed by a paediatrician with specific LUS expertise and blinded to clinical and radiological data. Receives: Device: Lung Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
LUS vs CXR in diagnosing pulmonary complications in bronchiolitis
To evaluate the use of LUS compared to CXR to diagnose pulmonary complications (pneumonia, pleural effusion, pneumothorax) in children with acute bronchiolitis
Measured: 12 hours
Secondary outcomes (2)
Sonographer inter-observer agreement
To evaluate the sonographer inter-observer agreement between a paediatrician and a paediatric radiologist in the diagnosing of pulmonary complications in children with acute bronchiolitis
Measured: 12 hours
LUS and severity of bronchiolitis
- To evaluate the correlation between clinical course and ultrasound findings in children with bronchiolitis.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study startFeb 2016
- Primary completionApr 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bronchiolitis AcuteStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- 87 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcello Lanari, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Marcello Lanari, Professor, Principal investigator, Pediatric Emergency Unit, S. Orsola-Malpighi Hospital, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280732
- Sponsor's protocol ID
- 13/2016/O/Sper
- Status last verified
- Feb 2022
- First submitted
- 10 Sep 2017
- Last updated
- 22 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742.
PubMed 25349312Parikh K, Hall M, Mittal V, Montalbano A, Mussman GM, Morse RB, Hain P, Wilson KM, Shah SS. Establishing benchmarks for the hospitalized care of children with asthma, bronchiolitis, and pneumonia. Pediatrics. 2014 Sep;134(3):555-62. doi: 10.1542/peds.2014-1052.
PubMed 25136044Florin TA, Byczkowski T, Ruddy RM, Zorc JJ, Test M, Shah SS. Variation in the management of infants hospitalized for bronchiolitis persists after the 2006 American Academy of Pediatrics bronchiolitis guidelines. J Pediatr. 2014 Oct;165(4):786-92.e1. doi: 10.1016/j.jpeds.2014.05.057. Epub 2014 Jul 9.
PubMed 25015578Mazrani W, McHugh K, Marsden PJ. The radiation burden of radiological investigations. Arch Dis Child. 2007 Dec;92(12):1127-31. doi: 10.1136/adc.2006.101782.
PubMed 18032642Copetti R, Cattarossi L. Ultrasound diagnosis of pneumonia in children. Radiol Med. 2008 Mar;113(2):190-8. doi: 10.1007/s11547-008-0247-8. Epub 2008 Apr 2. English, Italian.
PubMed 18386121Biagi C, Pierantoni L, Baldazzi M, Greco L, Dormi A, Dondi A, Faldella G, Lanari M. Lung ultrasound for the diagnosis of pneumonia in children with acute bronchiolitis. BMC Pulm Med. 2018 Dec 7;18(1):191. doi: 10.1186/s12890-018-0750-1.
PubMed 30526548
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound in Diagnosing and Monitoring of Pulmonary Complications in Children With Acute Bronchiolitis
- ClinicalTrials.gov ID
- NCT03280732
- Acronym / sponsor ID
- 13/2016/O/Sper
- Conditions
- Bronchiolitis Acute
- Keywords
- Lung Ultrasound, Chest X-Ray, Pneumonia, Pneumothorax, Pleural effusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 12 Sep 2017 (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.
Bronchiolitis is the leading cause of hospitalization in infants. The diagnosis is clinical and chest x-ray (CXR) should be reserved for severe cases in which signs of pulmonary complications are present. Nevertheless, CXR is performed in more than 50% of hospitalized patients with bronchiolitis, which exposes infants to ionizing radiation.
Data on the possible role of lung ultrasound (LUS) in children with bronchiolitis and suspected pulmonary complications have not been published yet.
The purpose of this study is to evaluate the use of LUS compared to CXR in diagnosing and monitoring pulmonary complications (pneumonia, pleural effusion, pneumothorax) in children with acute bronchiolitis. The second purpose of the study is to evaluate the correlation between clinical course and ultrasound findings in children with bronchiolitis.
The inclusion of LUS in the diagnostic work-up of bronchiolitis could possibly reduce the misuse of CXR in infants and the exposure to ionizing radiations.
Detailed description
Bronchiolitis is the most common lower respiratory tract infection that affects children younger than 24 months. The diagnosis is clinical and, according to international guidelines, chest x-ray (CXR) should be reserved for cases in which signs of pulmonary complications are present or where respiratory effort is severe to warrant intensive care unit admission. Despite these recommendations, CXR is still performed in about 50% of bronchiolitis (ranging from 24 to 77%), which exposes infants to ionizing radiation.
Given its portability, no ionizing radiation, rapid and repeat testing, lung ultrasound (LUS) has become an emerging diagnostic tool for pneumonia, pleural effusion and pneumothorax in adults and children. At present, LUS is not included in the diagnostic work-up of bronchiolitis. Previous papers have reported that LUS may be useful in bronchiolitis because of a good correlation between clinical course and ultrasound findings. However, data on the possible role of LUS in children with bronchiolitis and suspected pulmonary complications have not been published yet.
Enrolled patients will undergo a bedside LUS in the first 12 hours after CXR. LUS will be performed by one paediatrician with specific LUS expertise and blinded to clinical and radiological data. The paediatrician must have previously attended a specific course on LUS and supervised practical training. A Mindray-DC-T6 ultrasound machine equipped with a linear probe with frequencies ranging from 7.5 to 12 MHz will be use. LUS examination will consist of both longitudinal and transversal sections from the anterior, lateral and posterior chest wall according to the methodology described by Copetti et al. A radiologist will then independently repeat the LUS to test the sonographer inter-observer agreement. The radiologist will be blinded to the results of the previous studies (LUS and CXR). The LUS findings will be recorded on the data form together with patient demographics, symptoms, CXR findings and laboratory data.
Patients with LUS positive for pulmonary complications will receive follow-up ultrasound every 48 hours until the resolution or the discharge.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Ultrasound | Experimental | Device: Lung UltrasoundBedside lung ultrasound will be performed by a paediatrician with specific LUS expertise and blinded to clinical and radiological data. |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children hospitalized with a diagnosis of bronchiolitis
- Age < 24 months
- CXR as part of usual clinical practice because of clinical suspicion of pulmonary complications
- Informed written consent
Key exclusion criteria (4 listed)
- chronic respiratory disease (i.e. bronchopulmonary dysplasia)
- congenital heart disease
- severe neuromuscular disease
- congenital or acquired immunodeficiency
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 |
|---|---|---|
| Lung UltrasoundA Mindray-DC-T6 ultrasound machine equipped with a linear probe with frequencies ranging from 7.5 to 12 MHz will be use. LUS examination will consist of both longitudinal and transversal sections according to the methodology described by Copetti and colleagues. | Device | Lung Ultrasound |
Primary outcome
LUS vs CXR in diagnosing pulmonary complications in bronchiolitis
Time frame: 12 hours
To evaluate the use of LUS compared to CXR to diagnose pulmonary complications (pneumonia, pleural effusion, pneumothorax) in children with acute bronchiolitis
2 secondary outcomes
Sonographer inter-observer agreement
Time frame: 12 hours
LUS and severity of bronchiolitis
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Background: PubMed 25349312Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742.
- Background: PubMed 25136044Parikh K, Hall M, Mittal V, Montalbano A, Mussman GM, Morse RB, Hain P, Wilson KM, Shah SS. Establishing benchmarks for the hospitalized care of children with asthma, bronchiolitis, and pneumonia. Pediatrics. 2014 Sep;134(3):555-62. doi: 10.1542/peds.2014-1052.
- Background: PubMed 25015578Florin TA, Byczkowski T, Ruddy RM, Zorc JJ, Test M, Shah SS. Variation in the management of infants hospitalized for bronchiolitis persists after the 2006 American Academy of Pediatrics bronchiolitis guidelines. J Pediatr. 2014 Oct;165(4):786-92.e1. doi: 10.1016/j.jpeds.2014.05.057. Epub 2014 Jul 9.
- Background: PubMed 18032642Mazrani W, McHugh K, Marsden PJ. The radiation burden of radiological investigations. Arch Dis Child. 2007 Dec;92(12):1127-31. doi: 10.1136/adc.2006.101782.
- Background: PubMed 18386121Copetti R, Cattarossi L. Ultrasound diagnosis of pneumonia in children. Radiol Med. 2008 Mar;113(2):190-8. doi: 10.1007/s11547-008-0247-8. Epub 2008 Apr 2. English, Italian.
- Derived from this study: PubMed 30526548Biagi C, Pierantoni L, Baldazzi M, Greco L, Dormi A, Dondi A, Faldella G, Lanari M. Lung ultrasound for the diagnosis of pneumonia in children with acute bronchiolitis. BMC Pulm Med. 2018 Dec 7;18(1):191. doi: 10.1186/s12890-018-0750-1.
- 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.
Marcello Lanari, Professor principal investigator
Pediatric Emergency Unit, S. Orsola-Malpighi Hospital, University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Ultrasound in people with Bronchiolitis Acute, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 22 Feb 2022. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
LUS vs CXR in diagnosing pulmonary complications in bronchiolitis (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03280732, which also lists 6 linked publications.
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 22 Feb 2022.