<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/NCT01664507</url>
  </required_header>
  <id_info>
    <org_study_id>Croup_01</org_study_id>
    <nct_id>NCT01664507</nct_id>
  </id_info>
  <brief_title>The Effect and Safety of Low Dose Nebulized Epinephrine in Croup</brief_title>
  <official_title>The Effect and Safety of Low Dose Nebulized Epinephrine in the Treatment of Croup</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>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Croup is common illness presenting emergency department with dyspnea. The main treatment for&#xD;
      croup is nebulized L-epinephrine and steroid. The study for the dose of nebulized&#xD;
      L-epinephrine is restricted that the study of comparision between racemic epinephrine and&#xD;
      L-epinephrine.&#xD;
&#xD;
      The investigators conducted this study to compare the effectiveness of low dose L-epinephrine&#xD;
      with conventional dose L-epinephrine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">August 2018</completion_date>
  <primary_completion_date type="Anticipated">August 2018</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the difference of Westley croup score between baseline and 30 minutes after neublized treatment</measure>
    <time_frame>30 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the incidence of use of additional neublized treatment</measure>
    <time_frame>30 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Westley croup score</measure>
    <time_frame>30, 60, 90, 120, 180, 240 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the side effect of epinephrine</measure>
    <time_frame>participants will be followed for the duration of ED stay</time_frame>
    <description>Hypertension, tachycardia : more than 95th percentile for age Arrythmia Pallor Tremor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>respiratory rate, oxygen saturation</measure>
    <time_frame>30, 60, 90, 120, 180, 240 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>health care utilization- length of stay in emergency department, admission rate, revisit dut to croup symptom</measure>
    <time_frame>within 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>treatment failure</measure>
    <time_frame>30min after 2nd epinephrine nebulizer</time_frame>
    <description>after additional nebulized epineprhine at 30 minutes, as the croup scrore is higher than baselin, the blinding is cleared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rebound effect</measure>
    <time_frame>180 minutes</time_frame>
    <description>the croup score is the same or over than the base line</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Croup</condition>
  <condition>Epinephrine, Administration, Inhalation</condition>
  <arm_group>
    <arm_group_label>conventional dose epinephrine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>L-epinephrine (1:1000) 0.5 mL/kg (maximum 5mL) + normal saline : total 5mL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low dose epinephrine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>L-epinephrine (1:1000) 0.1 mL/kg (maximum 1mL) + normal saline : total 5mL</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>conventional dose epinephrine</intervention_name>
    <description>conventional dose epinephrine : 0.5mg/kg + 0.9% normal saline</description>
    <arm_group_label>conventional dose epinephrine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>low dose epinephrine</intervention_name>
    <description>low dose epineprhine : 0.1mg/kg + 0.9% normal saline</description>
    <arm_group_label>low dose epinephrine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  croup children between 6 month and 5 years old&#xD;
&#xD;
          -  Westley croup score between 3 and 11&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  underlying lung or heart disase&#xD;
&#xD;
          -  contra indication to dexamethasone&#xD;
&#xD;
          -  immune deficient state&#xD;
&#xD;
          -  preterm birth&#xD;
&#xD;
          -  previous intubation or apnea history&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin Hee Lee, Professor</last_name>
      <phone>+82-2-2072-4910</phone>
      <email>gienee74@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Jin Hee Lee, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hyuksool kwon, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 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>croup, dose, epinephrine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Laryngitis</mesh_term>
    <mesh_term>Croup</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Racepinephrine</mesh_term>
    <mesh_term>Epinephryl borate</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/NCT01664507
org study id: Croup_01
nct id: NCT01664507
lead sponsor: 
has dmc: Yes
Croup is common illness presenting emergency department with dyspnea. The main treatment for
      croup is nebulized L-epinephrine and steroid. The study for the dose of nebulized
      L-epinephrine is restricted that the study of comparision between racemic epinephrine and
      L-epinephrine.

      The investigators conducted this study to compare the effectiveness of low dose L-epinephrine
      with conventional dose L-epinephrine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: the difference of Westley croup score between baseline and 30 minutes after neublized treatment
time frame: 30 minutes
measure: the incidence of use of additional neublized treatment
time frame: 30 minutes
measure: Westley croup score
time frame: 30, 60, 90, 120, 180, 240 minutes
measure: the side effect of epinephrine
time frame: participants will be followed for the duration of ED stay
description: Hypertension, tachycardia : more than 95th percentile for age Arrythmia Pallor Tremor
measure: respiratory rate, oxygen saturation
time frame: 30, 60, 90, 120, 180, 240 minutes
measure: health care utilization- length of stay in emergency department, admission rate, revisit dut to croup symptom
time frame: within 7 days
measure: treatment failure
time frame: 30min after 2nd epinephrine nebulizer
description: after additional nebulized epineprhine at 30 minutes, as the croup scrore is higher than baselin, the blinding is cleared.
measure: rebound effect
time frame: 180 minutes
description: the croup score is the same or over than the base line
arm group label: conventional dose epinephrine
arm group type: Active Comparator
description: L-epinephrine (1:1000) 0.5 mL/kg (maximum 5mL) + normal saline : total 5mL
arm group label: low dose epinephrine
arm group type: Experimental
description: L-epinephrine (1:1000) 0.1 mL/kg (maximum 1mL) + normal saline : total 5mL
intervention type: Drug
intervention name: conventional dose epinephrine
description: conventional dose epinephrine : 0.5mg/kg + 0.9% normal saline
arm group label: conventional dose epinephrine
intervention type: Drug
intervention name: low dose epinephrine
description: low dose epineprhine : 0.1mg/kg + 0.9% normal saline
arm group label: low dose epinephrine
criteria: 
gender: All
minimum age: 6 Months
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
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: Laryngitis
mesh term: Croup
mesh term: Epinephrine
mesh term: Racepinephrine
mesh term: Epinephryl borate