<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/NCT03814954</url>
  </required_header>
  <id_info>
    <org_study_id>1812182</org_study_id>
    <nct_id>NCT03814954</nct_id>
  </id_info>
  <brief_title>Nebulized Epinephrine vs. Salbutamol in Bronchiolitis Among Children</brief_title>
  <official_title>Nebulized Epinephrine Versus Nebulized Salbutamol in Bronchiolitis Among Children Aged 1month-24months</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Makassed General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Makassed General Hospital</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>
      Acute bronchiolitis, mostly secondary to infection due to Respiratory syncytial virus (RSV)&#xD;
      is very common in infants under two years old. It is usually benign. However, the dyspnea it&#xD;
      causes is a big concern for parents and this disease can take a severe form on certain&#xD;
      particular ground thus constituting a frequent reason for hospitalization in pediatrics.&#xD;
      Nebulized epinephrine showed more efficacy than nebulized salbutamol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to determine if nebulized epinephrine is more efficacious than&#xD;
      nebulized salbutamol in all hospitalized children (1 month to 24 months) in treatment of&#xD;
      bronchiolitis. A randomized clinical trial which recruits children admitted to the pediatrics&#xD;
      department with diagnosis of bronchiolitis. Children aged 1 month to 2 years will be included&#xD;
      in the study.&#xD;
&#xD;
      Children who meet the inclusion criteria will be alternately distributed in two groups:&#xD;
&#xD;
      Group 1:&#xD;
&#xD;
      Will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer.&#xD;
&#xD;
      Group 2:&#xD;
&#xD;
      Will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer. All admitted&#xD;
      patients will receive aerosol every 20 minutes three times and after, depending on the&#xD;
      clinical status of the patients, they will be given oxygen therapy at 1.5 liters / minute at&#xD;
      the admission if oxygen saturation is below 94% till the normalization of the oxygen&#xD;
      saturation.&#xD;
&#xD;
      Clinical parameters such as clinical score, oxygen saturation with pulse oximetry, heart&#xD;
      rate, and temperature will be measured at admission, at hour 1 to hour 12 and then every 24&#xD;
      hours until they are discharged.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">August 31, 2021</completion_date>
  <primary_completion_date type="Actual">August 31, 2021</primary_completion_date>
  <phase>N/A</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of stay</measure>
    <time_frame>5 days</time_frame>
    <description>Patients hospitalization duration will be recorded</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Respiratory distress scoring</measure>
    <time_frame>5 days</time_frame>
    <description>The score will be measured through Silverman-Andersen Retraction scoring. The minimum score is 0 indicating no distress. The maximum score is 10 indicating severe respiratory distress</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Respiratory Distress Score</condition>
  <arm_group>
    <arm_group_label>Salbutamol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epinephrine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salbutamol</intervention_name>
    <description>At first day of admission, patients will receive 3 doses of nebulized salbutamol every 20 minutes. Then after 24 hours patients will receive standing dose according to clinical status</description>
    <arm_group_label>Salbutamol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epinephrine</intervention_name>
    <description>At first day of admission, patients will receive 3 doses of nebulized epinephrine every 20 minutes. Then after 24 hours patients will receive standing dose according to clinical status</description>
    <arm_group_label>Epinephrine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children diagnosed with acute bronchiolitis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with congenital heart disease or&#xD;
&#xD;
          -  chronic lung diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mariam Rajab, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Makassed General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Makassed General Hospital</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>August 28, 2022</last_update_submitted>
  <last_update_submitted_qc>August 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Makassed General Hospital</investigator_affiliation>
    <investigator_full_name>Mariam Rajab</investigator_full_name>
    <investigator_title>Clinical professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Albuterol</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/NCT03814954
org study id: 1812182
nct id: NCT03814954
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Acute bronchiolitis, mostly secondary to infection due to Respiratory syncytial virus (RSV)
      is very common in infants under two years old. It is usually benign. However, the dyspnea it
      causes is a big concern for parents and this disease can take a severe form on certain
      particular ground thus constituting a frequent reason for hospitalization in pediatrics.
      Nebulized epinephrine showed more efficacy than nebulized salbutamol.
The objective of this study is to determine if nebulized epinephrine is more efficacious than
      nebulized salbutamol in all hospitalized children (1 month to 24 months) in treatment of
      bronchiolitis. A randomized clinical trial which recruits children admitted to the pediatrics
      department with diagnosis of bronchiolitis. Children aged 1 month to 2 years will be included
      in the study.

      Children who meet the inclusion criteria will be alternately distributed in two groups:

      Group 1:

      Will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer.

      Group 2:

      Will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer. All admitted
      patients will receive aerosol every 20 minutes three times and after, depending on the
      clinical status of the patients, they will be given oxygen therapy at 1.5 liters / minute at
      the admission if oxygen saturation is below 94% till the normalization of the oxygen
      saturation.

      Clinical parameters such as clinical score, oxygen saturation with pulse oximetry, heart
      rate, and temperature will be measured at admission, at hour 1 to hour 12 and then every 24
      hours until they are discharged.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Length of stay
time frame: 5 days
description: Patients hospitalization duration will be recorded
measure: Respiratory distress scoring
time frame: 5 days
description: The score will be measured through Silverman-Andersen Retraction scoring. The minimum score is 0 indicating no distress. The maximum score is 10 indicating severe respiratory distress
arm group label: Salbutamol
arm group type: Active Comparator
description: Patients will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer.
arm group label: Epinephrine
arm group type: Experimental
description: Patients will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer.
intervention type: Drug
intervention name: Salbutamol
description: At first day of admission, patients will receive 3 doses of nebulized salbutamol every 20 minutes. Then after 24 hours patients will receive standing dose according to clinical status
arm group label: Salbutamol
intervention type: Drug
intervention name: Epinephrine
description: At first day of admission, patients will receive 3 doses of nebulized epinephrine every 20 minutes. Then after 24 hours patients will receive standing dose according to clinical status
arm group label: Epinephrine
criteria: 
gender: All
minimum age: 1 Month
maximum age: 24 Months
healthy volunteers: No
last name: Mariam Rajab, MD
role: Principal Investigator
affiliation: Makassed General Hospital
facility: 
country: Lebanon
responsible party type: Principal Investigator
investigator affiliation: Makassed General Hospital
investigator full name: Mariam Rajab
investigator title: Clinical professor
mesh term: Bronchiolitis
mesh term: Epinephrine
mesh term: Albuterol