<?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>IRCT20160523028008N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-22</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Treatment of respiratory distress syndrome in preterm infants</public_title>
      <acronym></acronym>
      <scientific_title>A randomized trial comparing surfactant administration using InSurE technique and the minimally invasive surfactant therapy in preterm infants at the age of 28 to 36 weeks of gestation and respiratory distress syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>112</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53461</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to the intervention and control groups using block randomization. The patients will be randomly assigned to the intervention and control groups using block randomization. Arrangement of the randomization process: 1) Determining the volume of each block (quadruple blocks) 2) Preparing the list of the blocks and assigning a number (between 1 and 6 ) to each of them 3)Choosing random numbers between 1 and 6 4) Defining the treatment assignment list, Blinding description: The person evaluating the outcome will be unaware of the type of intervention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Neonatal respiratory distress syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Participants take 200 mg/kg surfactant (Curosurf Chiesi Farmaceutici, Parma, Italy)by MIST method. Neonatal intubation and who are receiving2000 mg/kg surfactants in 1-3 minutes via feeding tube. Intervention 2: Intervention group: Participants take 200 mg/kg surfactant (Curosurf Chiesi Farmaceutici, Parma, Italy) by INSUR method.They receive  200 mg/kg surfactant in 1-3 minutes from a feeding tube via a thin intratracheal catheter (Insure method) during spontaneous breathing.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information"</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohamad Kazem Sabzehei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemiyeh Hospital, Kermanshah street, Hamedan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 81 3838 0717</telephone>
        <email>Mk_sabzehei@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohamad Kazem Sabzehei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemiyeh Hospital, Kermanshah street, Hamedan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838736</zip>
        <telephone>+98 81 3838 0717</telephone>
        <email>Mk_sabzehei@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gestational age of 28-37 weeks
With distress syndrome
Requiring Fraction of inspired oxygen&gt;40 
Treatment with surfactant in less than 24 hours after birth</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>28 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering of congenital heart abnormalities
APGAR score&lt;5
Suffering from any congenital disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P22.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Respiratory distress syndrome of newborn</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Participants take 200 mg/kg surfactant (Curosurf Chiesi Farmaceutici, Parma, Italy)by MIST method. Neonatal intubation and who are receiving2000 mg/kg surfactants in 1-3 minutes via feeding tube.</i_keyword>
      <i_keyword>Intervention group: Participants take 200 mg/kg surfactant (Curosurf Chiesi Farmaceutici, Parma, Italy) by INSUR method.They receive  200 mg/kg surfactant in 1-3 minutes from a feeding tube via a thin intratracheal catheter (Insure method) during spontaneous breathing.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Respiratory support. Timepoint: First week of birth. Method of measurement: Investigation of FIO2 and analysis of arterial blood gases.</prim_outcome>
      <prim_outcome>Hospitalization duration. Timepoint: During hospitalization. Method of measurement: Review of infant medical records.</prim_outcome>
      <prim_outcome>Mortality. Timepoint: During hospitalization. Method of measurement: Review of infant medical records.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-14</approval_date>
        <contact_name>Research Ethic Committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
