<?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>IRCT20230413057899N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-20</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>the effect of Ventolin in the treatment of bronchiolitis in children</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of inhaled beta2 agonist (Ventolin) in the treatment of bronchiolitis in children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73439</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done in blocks and a table will be prepared by computer and Excel software. The blocks will be binary combinations of AB, BA, BB, and AA, where each of the letters A and B will indicate standard treatment and Ventolin treatment, respectively. The patients were finally divided into 2 groups, Blinding description: Patients receive their treatment (intervention or control group) while receiving oxygen therapy (Ventolin nebulizers in hospital-grade nebulizer masks), which are coded. Coding is done by one of the colleagues of the project, and the doctor, evaluator, and patient are blinded to how the patients are coded.</study_design>
      <phase>3</phase>
      <hc_freetext>Bronchiolitis.</hc_freetext>
      <i_freetext>Intervention 1: The participants in this group, in addition to supportive treatment such as oxygen supplementation and receiving serum, are treated with a salbutamol nebulizer 0.15 mg per kilogram of body weight produced by GSK nebulizers, which will be prepared in coordination with the hospital pharmacy, first once every 20 minutes until One hour and then every 4 hours along with routine treatment. Intervention 2: Control group: supportive treatment including oxygen therapy and serum therapy is prescribed.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Only a part of the data, such as the information related to the main result or the like, can be shared.

When:
The access period starts 6 months after the results are published

To whom:
It will be available only to researchers working in academic and scientific institutions

Conditions:
Confirming the activities of researchers in academic and scientific institutions

Where to obtain:
Mehsa Sadat Nizam Taheri
m.nezamtaheri1369@gmail.com

How to obtain:
Formal request for access to data after 6 months of publication of the study
The data will be sent to the sent email within one month after the request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa sadat Nezam taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>22 bahman ave. tohid 9 str. no.5</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87159 88111</zip>
        <telephone>+98 31 5545 3757</telephone>
        <email>m.nezamtaheri1369@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahsa sadat Nezam taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>22 bahman ave. tohid 9 str. no.5</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87159 88111</zip>
        <telephone>+98 31 5545 3757</telephone>
        <email>m.nezamtaheri1369@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age less than 2 years</inclusion_criteria>
      <agemin>1 month</agemin>
      <agemax>2 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who will not be hospitalized due to the low severity of the disease
Immunodeficiency
Congenital heart disease
Congenital lung disease
Severe and mild severity of the disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute bronchiolitis</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>The participants in this group, in addition to supportive treatment such as oxygen supplementation and receiving serum, are treated with a salbutamol nebulizer 0.15 mg per kilogram of body weight produced by GSK nebulizers, which will be prepared in coordination with the hospital pharmacy, first once every 20 minutes until One hour and then every 4 hours along with routine treatment</i_keyword>
      <i_keyword>Control group: supportive treatment including oxygen therapy and serum therapy is prescribed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Respiratory rate. Timepoint: 1 hour and a half after starting the study. Method of measurement: Physical examination.</prim_outcome>
      <prim_outcome>Oxygen saturation. Timepoint: 1 hour and a half after starting the study. Method of measurement: Pulse oximetry device.</prim_outcome>
      <prim_outcome>Whizzing. Timepoint: 1 hour and a half after starting the study. Method of measurement: Physical examination.</prim_outcome>
      <prim_outcome>Retraction. Timepoint: 1 hour and a half after starting the study. Method of measurement: Physical examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Length of hospitalization. Timepoint: end of study. Method of measurement: number of days.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-30</approval_date>
        <contact_name>Research Ethics Committees of Faculty of Medicine &amp; Faculty of Dentistry- Kashan University of Medic</contact_name>
        <contact_address>56 Hekmat, Qutb Rawandi Boulevard, Kashan, Isfahan Province Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
