<?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>IRCT20190325043107N19</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-06</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Central vein catheter implantation in children</public_title>
      <acronym></acronym>
      <scientific_title>A comparison of open vs ultrasound-guided percutaneous insertion of central venous catheter in children weighting five kilograms or less.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51931</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into two groups by random allocation method. The balanced (permuted) block randomization will be used for random allocation and patients will be divided into two groups of intervention and placebo; Thus, first 6 possible modes of blocks (BAAB, ABBA, BABA, AABB, ABAB, BBAA) were listed and each block was assigned a number from 1 to 0. Then, a number between 1 and 0 was randomly selected and the subjects were assigned to the experimental group (A) and placebo (B) based on the relevant block and the selected number.</study_design>
      <phase>2</phase>
      <hc_freetext>The rate of infection in pediatric central venous catheter implantation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients will go to the operating room. Using a linear probe , the internal jugular vein is found and then the needle is inserted into the vein. After making sure that the needle is inside the vein and reads it, the guide wire enters the lumen of the left internal jugular vein through the needle. In this case, the presence of a guide wire in the internal jugular vein can also be confirmed by ultrasound. The needle is then removed but the guide wire remains inside the vein. Using a dilator, the path is cannulated through the guide wire. After this step, the dilator is removed and the central vein catheter is inserted into the internal jugular vein through the guide wire. After making sure that the catheter is inside the vein, the guide wire is removed and the catheter will be fixed on the skin using sutures. Intervention 2: Control group: Patients will enter the operating room. A small incision is made in the neck and the internal jugular vein is dissected and controlled, and a separate 5 mm long incision is made in the vein through which the central vein catheter is inserted without the use of a guidewire and under direct view through A venotomy is inserted, then repaired and fixed with an absorbable suture, and then the vein is repaired.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ibrahim Farhadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Childrens Hospital, Sheshgelan Ave</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5981764863</zip>
        <telephone>+98 41 3334 7054</telephone>
        <email>Khanbabayimehdi69@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ibrahim Farhadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Childrens Hospital, Sheshgelan Ave</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5981764863</zip>
        <telephone>+98 41 3334 7054</telephone>
        <email>Khanbabayimehdi69@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Weight less than 5 kg
Requires central venous catheter placement
First insertion of a central venous catheter
Consent to participate in the research project</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>3 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with hemophilia
INR rate greater than 1/5
Platelet count less than 100,000
CPR history
History of coagulation disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T80.21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Infection due to central venous catheter</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients will go to the operating room. Using a linear probe , the internal jugular vein is found and then the needle is inserted into the vein. After making sure that the needle is inside the vein and reads it, the guide wire enters the lumen of the left internal jugular vein through the needle. In this case, the presence of a guide wire in the internal jugular vein can also be confirmed by ultrasound. The needle is then removed but the guide wire remains inside the vein. Using a dilator, the path is cannulated through the guide wire. After this step, the dilator is removed and the central vein catheter is inserted into the internal jugular vein through the guide wire. After making sure that the catheter is inside the vein, the guide wire is removed and the catheter will be fixed on the skin using sutures.</i_keyword>
      <i_keyword>Control group: Patients will enter the operating room. A small incision is made in the neck and the internal jugular vein is dissected and controlled, and a separate 5 mm long incision is made in the vein through which the central vein catheter is inserted without the use of a guidewire and under direct view through A venotomy is inserted, then repaired and fixed with an absorbable suture, and then the vein is repaired.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The rate of infection in pediatric central venous catheter implantation. Timepoint: Once daily for up to three days after catheter placement. Method of measurement: Clinical examinations.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-23</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Children Hospital, Azadi Ave Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
