<?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>IRCT20181006041252N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-31</date_registration>
      <primary_sponsor>Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the comparison therapeutic effect of 5% saline versus 3% in the hospitalized patient with Acute Bronchiolitis.</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the comparison therapeutic effect of 5% saline versus 3% in the hospitalized patient with Acute Bronchiolitis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>94</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36165</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was conducted based on a permutation block, Accordingly, 47 blocks were allocated to patients, in each block, 2 were from following groups, treatment group A and group B. Eventually, after completing the blocks, Group A and B were treated with Nebulizer Saline 5% and Nebulizer Saline 3%, respectively, Blinding description: Each person will be assigned a study code A and B, which will only be known to the researcher of the type of groups. The person evaluating the outcome and the participants are unaware of the groups. It should be noted that saline  5% and 3% are similar in terms of appearance, color, and packaging.</study_design>
      <phase>3</phase>
      <hc_freetext>Acute Bronchiolitis.</hc_freetext>
      <i_freetext>Intervention 1: ّIntervention group: Patients in this group received 0.15 mg/kg Salbutamol and 5 cc nebulizer saline 5% and 8 liters of oxygen per minute while receiving nebulizers. Intervention 2: ّIntervention group: Patients in this group received 0.15 mg/kg Salbutamol and 5 cc nebulizer saline 3% and 8 liters of oxygen per minute while receiving nebulizers.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Alireza Asadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617913114</zip>
        <telephone>+98 51 4401 1604</telephone>
        <email>dralirezaasadi@gmail.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Alireza Asadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617913114</zip>
        <telephone>+98 51 4401 1604</telephone>
        <email>dralirezaasadi@gmail.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children aged 1 to 24 months with moderate to severe Bronchiolitis and clinical scores &gt;= 4</inclusion_criteria>
      <agemin>1 month</agemin>
      <agemax>24 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of underlying disease (cystic fibrosis, congenital heart disease, immune deficiency)
Get antibiotics before studying
Get Cortisone Inhaled and Systemic
Recent use of bronchodilators
History of immaturity and gestational age less than 32 weeks
Chronic pulmonary disease
History of NICU admission</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>ّIntervention group: Patients in this group received 0.15 mg/kg Salbutamol and 5 cc nebulizer saline 5% and 8 liters of oxygen per minute while receiving nebulizers.</i_keyword>
      <i_keyword>ّIntervention group: Patients in this group received 0.15 mg/kg Salbutamol and 5 cc nebulizer saline 3% and 8 liters of oxygen per minute while receiving nebulizers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determine the Modified Respiratory Assessment Score (MRAS). Timepoint: At the beginning of the study (before the intervention) and daily until discharge. Method of measurement: Using the modified respiratory assessment score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Determine the respiratory sounds (Vising). Timepoint: At the beginning of the study (before the intervention) and daily until discharge. Method of measurement: Auscultation of the lungs with Stethoscope.</sec_outcome>
      <sec_outcome>Respiratory Rate. Timepoint: At the beginning of the study (before the intervention) and daily until discharge. Method of measurement: The number of chest or abdominal cramps in 15 seconds or 1 minute.</sec_outcome>
      <sec_outcome>Determine the level of peripheral capillary oxygen saturation (SPO2). Timepoint: At the beginning of the study (before the intervention) and daily until discharge. Method of measurement: Pulse Oximeter or Oxygenometer.</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>Sabzevar University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-17</approval_date>
        <contact_name>Ethics committee of Sabzevar University of Medical Sciences</contact_name>
        <contact_address>Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
