<?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>IRCT20131012014988N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-26</date_registration>
      <primary_sponsor>Reasearch Deputy, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>efficacy of airway clearance therapy (ACT) on short time outcome of cystic fibrosis patients</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the efficacy of airway clearance therapy (ACT) on short time outcome of cystic fibrosis patients in tabriz chlidren’s hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28650</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>cystic fibrosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to antibiotic therapy and conventional chest physiotherapy, patients underwent NIV with BIPAP (NIV on days 2, 4 and 6 admitted for 2 hours) and PEP (on the second, fourth and sixth days on admission for 30 minutes) Placed. Intervention 2: Control group: The control group will be treated with antibiotics and conventional chest physiotherapy only. Ultimately, spirometry will be performed once per hospitalization and one day on discharge, and their differences will be compared with FEV1 and FVC.</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>Nemat Bilan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pediatric Health Research Center, Children Hospital, Sheshgelan street, Tabriz, Iran.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5136735886</zip>
        <telephone>+98 41 3526 2265</telephone>
        <email>phrc_mb@tbzmed.ac.ir</email>
        <affiliation>Pediatric Health Research Center, Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nemat Bilan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pediatric Health Research Center, Tabriz Children Hospital, Sheshgelan Street, Tabriz, Iran.</address>
        <city>TABRIZ</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5136735886</zip>
        <telephone>+98 41 3526 2265</telephone>
        <email>phrc_mb@tbzmed.ac.ir</email>
        <affiliation>Pediatric Health Research Center, Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>• Patients with CF diagnosis•
Patients aged 5 to 14 years•
Patients with exacerbation of lung disease with FEV1 = 20-70% in initial spirometry when admitted</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>14 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>• Patients with reluctance to continue participating in the study•
Patients who can not be traced to a cause such as death, transference to another city, etc. during the study period.•
Patients who do not have adequate compilation to continue treatment.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E84.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cystic fibrosis with pulmonary manifestations</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In addition to antibiotic therapy and conventional chest physiotherapy, patients underwent NIV with BIPAP (NIV on days 2, 4 and 6 admitted for 2 hours) and PEP (on the second, fourth and sixth days on admission for 30 minutes) Placed</i_keyword>
      <i_keyword>Control group: The control group will be treated with antibiotics and conventional chest physiotherapy only. Ultimately, spirometry will be performed once per hospitalization and one day on discharge, and their differences will be compared with FEV1 and FVC.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Forced expiratory volume in the first second. Timepoint: In the second and last day of the admission. Method of measurement: By using spirometry device.</prim_outcome>
      <prim_outcome>FEV1/FVC. Timepoint: In the second and last day of the admission. Method of measurement: By using spirometry device.</prim_outcome>
      <prim_outcome>Peak expiratory flow. Timepoint: In the second and last day of the admission. Method of measurement: By using peak flow-meter device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Number of Exacerebration within six months. Timepoint: within six months. Method of measurement: Cheklist.</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>Reasearch Deputy, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-04</approval_date>
        <contact_name>Regional Ethics Committee, Office of the Vice Chancellor for Research, Tabriz University of Medical</contact_name>
        <contact_address>تبریز-خیابان دانشگاه-ساختمان مرکزی شماره 2 دانشگاه علوم پزشکی تبریز- طبقه سوم-معاونت تحقیقات و فن آوری دانشگاه علوم پزشکی تبریز tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
