<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT201105264396N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-06-13</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>The effect of dexamethasone and dexamethasone with nebulised L-epinephrine in treatment of croup.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of dexamethasone and dexamethasone with nebulised L-epinephrine in treatment of croup.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>94</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4688</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Croup.</hc_freetext>
      <i_freetext>Intervention 1: In this study, control group, will be treated with 0.6mg/kg intramuscular Dexamethasone at a single dose and 3cc nebulized N/S.&#13;
Before treatment and 30 and 60 minutes after treatment, croup score and respiratory rate per minute will be calculated for each patient and age, gender, duration of stay in the emergency ward and hospitalization status will be recorded. Croup diagnosis will be based on clinical signs and croup scoring according to asthma and allergy specialist’s scoring. Intervention 2: In this study, the case group will be treated with 0.6mg/kg intramuscular Dexamethasone at a single dose and nebulized epinephrine (0.5mL of 1:1000 (1mg/mL) in 3mL N/S for less than 10kg weight and 1mL for more than 10kg weight.&#13;
Before treatment and 30 and 60 minutes after treatment, croup score and respiratory rate per minute will be calculated for each patient and age, gender, duration of stay in the emergency ward and hospitalization status will be recorded. Croup diagnosis will be based on clinical signs and croup scoring according to asthma and allergy specialist’s scoring.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Iraj Mohammadzadeh M.D</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol. Amirkola Children's Hospital</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4731741151</zip>
        <telephone>+98 11 1324 2151</telephone>
        <email>i.mohammadzadeh@mubabol.ac.ir</email>
        <affiliation>Amirkola Children's Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Iraj Mohammadzadeh M.D</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol, Amirkola Children's Hospital</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4731741151</zip>
        <telephone>+98 11 1324 2151</telephone>
        <email>i.mohammadzadeh@mubabol.ac.ir</email>
        <affiliation>Non-Communicable pediatric diseases research cente, Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: children aged 6months to 6years old suffering from croup.&#13;
Exclusion criteria: receiving steroid during last month, asthma, pneumonia, congenital heart diseases.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J05.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute obstructive laryngitis [croup]</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, control group, will be treated with 0.6mg/kg intramuscular Dexamethasone at a single dose and 3cc nebulized N/S.&#13;
Before treatment and 30 and 60 minutes after treatment, croup score and respiratory rate per minute will be calculated for each patient and age, gender, duration of stay in the emergency ward and hospitalization status will be recorded. Croup diagnosis will be based on clinical signs and croup scoring according to asthma and allergy specialist’s scoring.</i_keyword>
      <i_keyword>In this study, the case group will be treated with 0.6mg/kg intramuscular Dexamethasone at a single dose and nebulized epinephrine (0.5mL of 1:1000 (1mg/mL) in 3mL N/S for less than 10kg weight and 1mL for more than 10kg weight.&#13;
Before treatment and 30 and 60 minutes after treatment, croup score and respiratory rate per minute will be calculated for each patient and age, gender, duration of stay in the emergency ward and hospitalization status will be recorded. Croup diagnosis will be based on clinical signs and croup scoring according to asthma and allergy specialist’s scoring.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Croup Score. Timepoint: Before treatment, 30min after treatment and 1 hour after treatment. Method of measurement: Number(0-6).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hospitalization, Duration of stay in emergency,Respiratory Rate. Timepoint: nothing. Method of measurement: Yes/No,Hour,Number.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-02-28</approval_date>
        <contact_name>Babol University of Medical Siences</contact_name>
        <contact_address>Babol,Ganjafrooz Street Babol  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
