<?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>IRCT2017062034653N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-09</date_registration>
      <primary_sponsor>Researcher is sponser-</primary_sponsor>
      <public_title>The comparison of chlorhexidine and povidone-iodine alcohol on bacterial colonization after peripheral vascular catheter insertion .</public_title>
      <acronym>-</acronym>
      <scientific_title>The comparison of chlorhexidine with povidone-iodine alcohol on bacterial colonization after peripheral vascular catheter insertion</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26437</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: The quadruple blocking method was used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>skin disinfection.</hc_freetext>
      <i_freetext>Intervention 1: control group:  used Povidone10% -iodine alcohol 70% for skin disinfection for peripheral catheter placement. Intervention 2: intervention group: In the intervention group, the infants entering the study were treated with 2% chlorhexidine, antiseptic venulation, and then catheterization.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Tyebi Myaneh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Number 118, emam mosay kazem, alborz industry city, Qazvin.</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3431463938</zip>
        <telephone>+98 28 3224 8614</telephone>
        <email>tayebi.medical@gmail.comz.tayebi@qums.ac.ir</email>
        <affiliation>Qazvin University of medical science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Tayebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Number 118, emam mosay kazem, Alborz Industrial City, Qazvin.</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 28 3224 8614</telephone>
        <email>tayebi.medical@gmail.com; z.tayebi@qums.ac.ir</email>
        <affiliation>Qazvin university of medical science.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Premature infants in intensive care units; Infants who need vascular catheter insertion for the first time; Absence of inflammation in the vein site; No symptoms of septicemia; No bacteremia. Exclusion criteria: Failure to catheterization after first try; Use an antiseptic solution at the place of catheterization twice or more.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B95-B98</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>These categories should never be used in primary coding. They are provided for use as supplementary or additional codes when it is desired to identify the infectious agent(s) in diseases classified elsewhere.</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>control group:  used Povidone10% -iodine alcohol 70% for skin disinfection for peripheral catheter placement.</i_keyword>
      <i_keyword>intervention group: In the intervention group, the infants entering the study were treated with 2% chlorhexidine, antiseptic venulation, and then catheterization.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of colonization. Timepoint: 72 hours after culturing from catheter tip. Method of measurement: Control the number of colonies grown in culture environment.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Type of colonies grown. Timepoint: 72 hours after catheter tip sampling. Method of measurement: Control the number of colonies grown in culture environment.</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>Researcher is sponser-</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-11-01</approval_date>
        <contact_name>Etics committee of Qazvin University of medical science</contact_name>
        <contact_address>University of medical science, Shahid bahonar bolvar, Qazvin.s. Qazvin  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
