Use of Lung Ultrasound in Children With Acute Bronchiolitis
Primary Purpose
Bronchiolitis Acute
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lung Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Bronchiolitis Acute focused on measuring Lung Ultrasound, Chest X-Ray, Pneumonia, Pneumothorax, Pleural effusion
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- chronic respiratory disease (i.e. bronchopulmonary dysplasia)
- congenital heart disease
- severe neuromuscular disease
- congenital or acquired immunodeficiency
Sites / Locations
- Pediatric Emergency Unit, S. Orsola-Malpighi Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lung Ultrasound
Arm Description
Bedside lung ultrasound will be performed by a paediatrician with specific LUS expertise and blinded to clinical and radiological data.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
LUS and severity of bronchiolitis
- To evaluate the correlation between clinical course and ultrasound findings in children with bronchiolitis.
Full Information
NCT ID
NCT03280732
First Posted
September 10, 2017
Last Updated
February 21, 2022
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1. Study Identification
Unique Protocol Identification Number
NCT03280732
Brief Title
Use of Lung Ultrasound in Children With Acute Bronchiolitis
Official Title
Lung Ultrasound in Diagnosing and Monitoring of Pulmonary Complications in Children With Acute Bronchiolitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis Acute
Keywords
Lung Ultrasound, Chest X-Ray, Pneumonia, Pneumothorax, Pleural effusion
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lung Ultrasound
Arm Type
Experimental
Arm Description
Bedside lung ultrasound will be performed by a paediatrician with specific LUS expertise and blinded to clinical and radiological data.
Intervention Type
Device
Intervention Name(s)
Lung Ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
LUS vs CXR in diagnosing pulmonary complications in bronchiolitis
Description
To evaluate the use of LUS compared to CXR to diagnose pulmonary complications (pneumonia, pleural effusion, pneumothorax) in children with acute bronchiolitis
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Sonographer inter-observer agreement
Description
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
Time Frame
12 hours
Title
LUS and severity of bronchiolitis
Description
- To evaluate the correlation between clinical course and ultrasound findings in children with bronchiolitis.
Time Frame
12 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
chronic respiratory disease (i.e. bronchopulmonary dysplasia)
congenital heart disease
severe neuromuscular disease
congenital or acquired immunodeficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcello Lanari, Professor
Organizational Affiliation
Pediatric Emergency Unit, S. Orsola-Malpighi Hospital, University of Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Emergency Unit, S. Orsola-Malpighi Hospital
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25349312
Citation
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. Erratum In: Pediatrics. 2015 Oct;136(4):782.
Results Reference
background
PubMed Identifier
25136044
Citation
Parikh 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.
Results Reference
background
PubMed Identifier
25015578
Citation
Florin 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.
Results Reference
background
PubMed Identifier
18032642
Citation
Mazrani 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.
Results Reference
background
PubMed Identifier
18386121
Citation
Copetti 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.
Results Reference
background
PubMed Identifier
30526548
Citation
Biagi 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.
Results Reference
derived
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Use of Lung Ultrasound in Children With Acute Bronchiolitis
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