<?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>IRCT20190206042639N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-24</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The comparison between intravenous acetaminophen versus oral ibuprofen in preterm newborns with patent ductus arteriosus</public_title>
      <acronym></acronym>
      <scientific_title>The comparison between intravenous acetaminophen versus oral ibuprofen in preterm newborns with patent ductus arteriosus</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37441</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Oral ibuprofen is a commonly used drug for treating PDA in premature infants in Iran.Contraindications for use in premature infants admitted to the NICU are abundant.The particular feature of our study was that  we used intravenous acetaminophen (apotel) for patients who were contraindicated in taking ibuprofen and having a hemodinamicaly significant  PDA. Therefore, patients who were normally deprived of treatment were treated with intravenous acetaminophen, Blinding description: Participants (premature infants) have no information about prescribing drugs.
The data analyzer has no information about type of Prescribing drugs.
Safety Committee and Data Supervision has no information about type of Prescribing drugs.</study_design>
      <phase>3</phase>
      <hc_freetext>Patent Ductus Arteriosus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Oral ibuprofen with a dose of 10 mg per kg on the first day and then 5 mg per kilogram in the next two doses at intervals of 24 and 48 hours. Intervention 2: Intervention group: Intravenous Acetaminophen With a dose of 10 mg per kg body weight every 6 hours up to a maximum of 60 mg per kg per day for 3 days.</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 So far, I have not decided on this, but I plan to provide a suitable program for its release.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeinab Harif Nashtifani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 26, Vatani Alley, Kavosifar, Beheshti Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1577814935</zip>
        <telephone>+98 21 8852 4107</telephone>
        <email>HRF.Z24@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behzad Mohammadpour Ahrendani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Children's Department,Valiasr Hospital,Imam Khomeini Hospital complex, End of keshavarz Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6119 2361</telephone>
        <email>behzadpediatr@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Premature infants with hemodynamicaiy significant Patent Ductus Arteriosus
Premature infant with a gestational age of less than 37 weeks and a birth weight of less than or equal to 2500 grams</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>15 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Ductal dependent congenital Heart diseases
Life threatening infections
Syndromic manifestations
Persistent Pulmonary Hypertention</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Q25.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Patent ductus arteriosus</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: Oral ibuprofen with a dose of 10 mg per kg on the first day and then 5 mg per kilogram in the next two doses at intervals of 24 and 48 hours</i_keyword>
      <i_keyword>Intervention group: Intravenous Acetaminophen With a dose of 10 mg per kg body weight every 6 hours up to a maximum of 60 mg per kg per day for 3 days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Closure of PDA in preterm infants. Timepoint: Echocardiography  at  3 to 15 days of birth (before starting treatment), 4 days after starting treatment. Method of measurement: Echocardiographicaly.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Requires a second course of medical treatment. Timepoint: The day after the first course of medical treatment. Method of measurement: Ecocardiographicaly.</sec_outcome>
      <sec_outcome>Need for surgical treatment. Timepoint: The day after the second course of medical treatment. Method of measurement: Ecocardiographicaly.</sec_outcome>
      <sec_outcome>Increased serum creatinine. Timepoint: Any time after initiation of medical treatment. Method of measurement: Physical examination &amp; laboratory tests.</sec_outcome>
      <sec_outcome>Incidence of pulmonary hemorrhage. Timepoint: Any time after initiation of medical treatment. Method of measurement: Physical examination &amp; CXR.</sec_outcome>
      <sec_outcome>Incidence of intraventricular hemorrhage. Timepoint: Any time after initiation of medical treatment. Method of measurement: Physical examination &amp; brain sonography.</sec_outcome>
      <sec_outcome>Incidence of gastrointestinal bleeding. Timepoint: Any time after initiation of medical treatment. Method of measurement: Physical examination &amp; laboratory tests.</sec_outcome>
      <sec_outcome>Incidence of necrotizing enterocolitis. Timepoint: Any time after initiation of medical treatment. Method of measurement: Clinical and Paraclinical Examination.</sec_outcome>
      <sec_outcome>Impaired liver function tests. Timepoint: Any time after initiation of medical treatment. Method of measurement: Clinical examination and laboratory tests.</sec_outcome>
      <sec_outcome>Hyperbilirubinemia. Timepoint: Any time after initiation of medical treatment. Method of measurement: Clinical examination and laboratory tests.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-22</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Keshavarz Blv, Qods Streat, Tehran Univercity of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
