<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/NCT01660867</url>
  </required_header>
  <id_info>
    <org_study_id>Bronchiolitis_1</org_study_id>
    <nct_id>NCT01660867</nct_id>
  </id_info>
  <brief_title>Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department</brief_title>
  <official_title>Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <brief_summary>
    <textblock>
      This is a prospective, randomized, controlled, double-blinded, clinical trial&#xD;
&#xD;
      Subject : 3mo ~ 24mo. aged infants with bronchiolitis&#xD;
&#xD;
      The effect of 3 % NaCl nebulizer or dexamethasone on admission rate of these infants in ED.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomly assigned to one of three groups&#xD;
&#xD;
        -  Group I : nebulized epinephrine + 0.9% saline + placebo&#xD;
&#xD;
        -  Group II : nebulized epinephrine + 3% saline + placebo&#xD;
&#xD;
        -  Group III : nebulized epinephrine + 0.9% saline + dexamethasone&#xD;
&#xD;
      Group I received two treatments of nebulized epinephrine mixed 0.9% saline and a total of six&#xD;
      oral doses of placebo, group II received nebulized epinephrine mixed 3% saline and oral&#xD;
      placebo, and group III received nebulized epinephrine mixed 0.9% saline and oral&#xD;
      dexamethasone.&#xD;
&#xD;
      The primary outcome is hospital admission within 7 days after the day of enrollment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    there was no eligible patients&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>hospital admission within 7 days after the day of enrollment</measure>
    <time_frame>within 7 days</time_frame>
    <description>hospital admission within 7 days after the day of enrollment(the initial visit to the emergency department)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>RDAI score</measure>
    <time_frame>baseline, between nebulizer, 60min, 120min, 180min, 240min</time_frame>
    <description>RDAI score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>respiratory rate</measure>
    <time_frame>baseline, between nebulizer, 60min, 120min, 180min, 240min</time_frame>
    <description>respiratory rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>baseline, between nebulizer, 60min, 120min, 180min, 240min</time_frame>
    <description>Heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation</measure>
    <time_frame>baseline, between nebulizer, 60min, 120min, 180min, 240min</time_frame>
    <description>Oxygen saturation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>unplanned revisit and admission rate after revisit</measure>
    <time_frame>in 7days</time_frame>
    <description>unplanned revisit admission rate after revisit</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Acute Bronchiolitis</condition>
  <arm_group>
    <arm_group_label>0.9% saline + oral placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>nebulized epinephrine + 0.9% saline + placebo =&gt; epinephrine + 0.9% saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3% saline + oral placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>nebulized epinephrine + 3% saline + placebo =&gt; nebulized epinephrine + 3% saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.9% saline + oral dexamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>nebulized epinephrine + 0.9% saline + dexamethasone =&gt; nebulized epinephrine + 0.9% saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>3% saline + oral placebo</intervention_name>
    <description>nebulized epinephrine + 3% saline + placebo =&gt; nebulized epinephrine + 3% saline</description>
    <arm_group_label>3% saline + oral placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.9% saline + oral dexamethasone</intervention_name>
    <description>nebulized epinephrine + 0.9% saline + dexamethasone =&gt; nebulized epinephrine + 0.9% saline</description>
    <arm_group_label>0.9% saline + oral dexamethasone</arm_group_label>
    <arm_group_label>0.9% saline + oral placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  3mo ~ 24mo aged patients with bronchiolitis visit to emergency departments&#xD;
&#xD;
          -  RDAI score 4-15&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 3mo, &gt; 24mo&#xD;
&#xD;
          -  infants who had received oral or inhaled corticosteroids during the preceding 2 weeks&#xD;
&#xD;
          -  infants with a previous episode of wheezing or a diagnosis of asthma&#xD;
&#xD;
          -  any chronic cardiopulmonary disease&#xD;
&#xD;
          -  immunodeficiency&#xD;
&#xD;
          -  infants needed intubation&#xD;
&#xD;
          -  infants with a previous history of apnea or intubation&#xD;
&#xD;
          -  infants with side effect of dexamethasone&#xD;
&#xD;
          -  infants born at less than 37 weeks of gestation who had a corrected age of less than 6&#xD;
             weeks at presentation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 3, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>January 6, 2018</last_update_submitted>
  <last_update_submitted_qc>January 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jin Hee Lee</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>hospital admission within 7 days of 3% NaCl nebulizer vs dexamethasone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01660867
org study id: Bronchiolitis_1
nct id: NCT01660867
lead sponsor: 
This is a prospective, randomized, controlled, double-blinded, clinical trial

      Subject : 3mo ~ 24mo. aged infants with bronchiolitis

      The effect of 3 % NaCl nebulizer or dexamethasone on admission rate of these infants in ED.
Randomly assigned to one of three groups

        -  Group I : nebulized epinephrine + 0.9% saline + placebo

        -  Group II : nebulized epinephrine + 3% saline + placebo

        -  Group III : nebulized epinephrine + 0.9% saline + dexamethasone

      Group I received two treatments of nebulized epinephrine mixed 0.9% saline and a total of six
      oral doses of placebo, group II received nebulized epinephrine mixed 3% saline and oral
      placebo, and group III received nebulized epinephrine mixed 0.9% saline and oral
      dexamethasone.

      The primary outcome is hospital admission within 7 days after the day of enrollment
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: hospital admission within 7 days after the day of enrollment
time frame: within 7 days
description: hospital admission within 7 days after the day of enrollment(the initial visit to the emergency department)
measure: RDAI score
time frame: baseline, between nebulizer, 60min, 120min, 180min, 240min
description: RDAI score
measure: respiratory rate
time frame: baseline, between nebulizer, 60min, 120min, 180min, 240min
description: respiratory rate
measure: Heart rate
time frame: baseline, between nebulizer, 60min, 120min, 180min, 240min
description: Heart rate
measure: Oxygen saturation
time frame: baseline, between nebulizer, 60min, 120min, 180min, 240min
description: Oxygen saturation
measure: unplanned revisit and admission rate after revisit
time frame: in 7days
description: unplanned revisit admission rate after revisit
arm group label: 0.9% saline + oral placebo
arm group type: Placebo Comparator
description: nebulized epinephrine + 0.9% saline + placebo => epinephrine + 0.9% saline
arm group label: 3% saline + oral placebo
arm group type: Experimental
description: nebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline
arm group label: 0.9% saline + oral dexamethasone
arm group type: Active Comparator
description: nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline
intervention type: Drug
intervention name: 3% saline + oral placebo
description: nebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline
arm group label: 3% saline + oral placebo
intervention type: Drug
intervention name: 0.9% saline + oral dexamethasone
description: nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline
arm group label: 0.9% saline + oral dexamethasone
arm group label: 0.9% saline + oral placebo
criteria: 
gender: All
minimum age: 3 Months
maximum age: 24 Months
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jin Hee Lee
investigator title: Assistant Professor
mesh term: Bronchiolitis
mesh term: Emergencies
mesh term: Dexamethasone