<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03280732</url>
  </required_header>
  <id_info>
    <org_study_id>13/2016/O/Sper</org_study_id>
    <nct_id>NCT03280732</nct_id>
  </id_info>
  <brief_title>Use of Lung Ultrasound in Children With Acute Bronchiolitis</brief_title>
  <official_title>Lung Ultrasound in Diagnosing and Monitoring of Pulmonary Complications in Children With Acute Bronchiolitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Azienda Ospedaliero-Universitaria di Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Azienda Ospedaliero-Universitaria di Bologna</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bronchiolitis is the leading cause of hospitalization in infants. The diagnosis is clinical&#xD;
      and chest x-ray (CXR) should be reserved for severe cases in which signs of pulmonary&#xD;
      complications are present. Nevertheless, CXR is performed in more than 50% of hospitalized&#xD;
      patients with bronchiolitis, which exposes infants to ionizing radiation.&#xD;
&#xD;
      Data on the possible role of lung ultrasound (LUS) in children with bronchiolitis and&#xD;
      suspected pulmonary complications have not been published yet.&#xD;
&#xD;
      The purpose of this study is to evaluate the use of LUS compared to CXR in diagnosing and&#xD;
      monitoring pulmonary complications (pneumonia, pleural effusion, pneumothorax) in children&#xD;
      with acute bronchiolitis. The second purpose of the study is to evaluate the correlation&#xD;
      between clinical course and ultrasound findings in children with bronchiolitis.&#xD;
&#xD;
      The inclusion of LUS in the diagnostic work-up of bronchiolitis could possibly reduce the&#xD;
      misuse of CXR in infants and the exposure to ionizing radiations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bronchiolitis is the most common lower respiratory tract infection that affects children&#xD;
      younger than 24 months. The diagnosis is clinical and, according to international guidelines,&#xD;
      chest x-ray (CXR) should be reserved for cases in which signs of pulmonary complications are&#xD;
      present or where respiratory effort is severe to warrant intensive care unit admission.&#xD;
      Despite these recommendations, CXR is still performed in about 50% of bronchiolitis (ranging&#xD;
      from 24 to 77%), which exposes infants to ionizing radiation.&#xD;
&#xD;
      Given its portability, no ionizing radiation, rapid and repeat testing, lung ultrasound (LUS)&#xD;
      has become an emerging diagnostic tool for pneumonia, pleural effusion and pneumothorax in&#xD;
      adults and children. At present, LUS is not included in the diagnostic work-up of&#xD;
      bronchiolitis. Previous papers have reported that LUS may be useful in bronchiolitis because&#xD;
      of a good correlation between clinical course and ultrasound findings. However, data on the&#xD;
      possible role of LUS in children with bronchiolitis and suspected pulmonary complications&#xD;
      have not been published yet.&#xD;
&#xD;
      Enrolled patients will undergo a bedside LUS in the first 12 hours after CXR. LUS will be&#xD;
      performed by one paediatrician with specific LUS expertise and blinded to clinical and&#xD;
      radiological data. The paediatrician must have previously attended a specific course on LUS&#xD;
      and supervised practical training. A Mindray-DC-T6 ultrasound machine equipped with a linear&#xD;
      probe with frequencies ranging from 7.5 to 12 MHz will be use. LUS examination will consist&#xD;
      of both longitudinal and transversal sections from the anterior, lateral and posterior chest&#xD;
      wall according to the methodology described by Copetti et al. A radiologist will then&#xD;
      independently repeat the LUS to test the sonographer inter-observer agreement. The&#xD;
      radiologist will be blinded to the results of the previous studies (LUS and CXR). The LUS&#xD;
      findings will be recorded on the data form together with patient demographics, symptoms, CXR&#xD;
      findings and laboratory data.&#xD;
&#xD;
      Patients with LUS positive for pulmonary complications will receive follow-up ultrasound&#xD;
      every 48 hours until the resolution or the discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2016</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>LUS vs CXR in diagnosing pulmonary complications in bronchiolitis</measure>
    <time_frame>12 hours</time_frame>
    <description>To evaluate the use of LUS compared to CXR to diagnose pulmonary complications (pneumonia, pleural effusion, pneumothorax) in children with acute bronchiolitis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sonographer inter-observer agreement</measure>
    <time_frame>12 hours</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LUS and severity of bronchiolitis</measure>
    <time_frame>12 hours</time_frame>
    <description>- To evaluate the correlation between clinical course and ultrasound findings in children with bronchiolitis.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Bronchiolitis Acute</condition>
  <arm_group>
    <arm_group_label>Lung Ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bedside lung ultrasound will be performed by a paediatrician with specific LUS expertise and blinded to clinical and radiological data.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lung Ultrasound</intervention_name>
    <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.</description>
    <arm_group_label>Lung Ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children hospitalized with a diagnosis of bronchiolitis&#xD;
&#xD;
          -  Age &lt; 24 months&#xD;
&#xD;
          -  CXR as part of usual clinical practice because of clinical suspicion of pulmonary&#xD;
             complications&#xD;
&#xD;
          -  Informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic respiratory disease (i.e. bronchopulmonary dysplasia)&#xD;
&#xD;
          -  congenital heart disease&#xD;
&#xD;
          -  severe neuromuscular disease&#xD;
&#xD;
          -  congenital or acquired immunodeficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcello Lanari, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pediatric Emergency Unit, S. Orsola-Malpighi Hospital, University of Bologna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pediatric Emergency Unit, S. Orsola-Malpighi Hospital</name>
      <address>
        <city>Bologna</city>
        <state>BO</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>25349312</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25136044</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25015578</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18032642</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18386121</PMID>
  </reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>September 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>February 21, 2022</last_update_submitted>
  <last_update_submitted_qc>February 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Azienda Ospedaliero-Universitaria di Bologna</investigator_affiliation>
    <investigator_full_name>Marcello Lanari</investigator_full_name>
    <investigator_title>Director, Professor</investigator_title>
  </responsible_party>
  <keyword>Lung Ultrasound</keyword>
  <keyword>Chest X-Ray</keyword>
  <keyword>Pneumonia</keyword>
  <keyword>Pneumothorax</keyword>
  <keyword>Pleural effusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03280732
org study id: 13/2016/O/Sper
nct id: NCT03280732
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: LUS vs CXR in diagnosing pulmonary complications in bronchiolitis
time frame: 12 hours
description: To evaluate the use of LUS compared to CXR to diagnose pulmonary complications (pneumonia, pleural effusion, pneumothorax) in children with acute bronchiolitis
measure: Sonographer inter-observer agreement
time frame: 12 hours
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
measure: LUS and severity of bronchiolitis
time frame: 12 hours
description: - To evaluate the correlation between clinical course and ultrasound findings in children with bronchiolitis.
arm group label: Lung Ultrasound
arm group type: Experimental
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: Lung Ultrasound
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.
arm group label: Lung Ultrasound
criteria: 
gender: All
minimum age: N/A
maximum age: 24 Months
healthy volunteers: No
last name: Marcello Lanari, Professor
role: Principal Investigator
affiliation: Pediatric Emergency Unit, S. Orsola-Malpighi Hospital, University of Bologna
facility: 
country: Italy
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.
PMID: 25349312
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.
PMID: 25136044
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.
PMID: 25015578
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.
PMID: 18032642
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.
PMID: 18386121
responsible party type: Principal Investigator
investigator affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
investigator full name: Marcello Lanari
investigator title: Director, Professor
mesh term: Bronchiolitis
sharing ipd: No