<?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>IRCT138903204113N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-11-28</date_registration>
      <primary_sponsor>Pediatric health research  center of Tabriz university of medical sceinces</primary_sponsor>
      <public_title>Benefits and complication of peripherally inserted central catheter (PICC) versus peripherally Intravenous Vein lines</public_title>
      <acronym></acronym>
      <scientific_title>Early Outcome of peripheraly inserted central catheter(PICC)versus peripheraly conulation(PC) in very low birth weight (VLBW)infants.   infants</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-05-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>114</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4335</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Very low Birth Weight Infants.</hc_freetext>
      <i_freetext>Intervention 1: After  randomization in two paralel groups , UVC will  remove and a PICC will  place at 3-7 days after birth in one group of the study . Using sterile technique, one specially trained neonatal nurse with cooperation of Neonatology fellowship will  place the PICCs.Catheters made by Vygon company with  2 French caliber  with breakable introducer needles will use. Three betadine swabs, with at least 1 min drying time for each, will be  use when placing the PICCs.  All PICCs will  place in the upper limbs; placement of these lines will  confirme at T4 to T6 level  by radiograph.  Trained nurses are   responsible for changing the PICC dressings.  The PICCs will monitore daily to ensure that the PICC dressing is  occlusive.  when necessary, the dressing will change. Intervention 2: In  the other group after removing UVC with a   clean technique, place the peripheral IV lines.</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>Dr. Ahmmad Safary</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alzahra teaching hospital, Artesh street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5165685783</zip>
        <telephone>+98 41 1553 9161</telephone>
        <email>hovalalim@yahoo.com</email>
        <affiliation>Tabriz University of Medica Sceinces</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Bagher Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alzahra teaching hospital, Artesh Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1553 9161</telephone>
        <email>Hosseini_mb@yahoo.com</email>
        <affiliation>Tabriz University of Medical University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
 Very Low Birth Weight neonates who will be born in Al-Zahra teaching hospital of Tabriz; without lethal congenital anomaly and chromosomal disorders; Absent major congenital heart disease; Absent hemorrhagic disorders; Absent generalized skin disorders or skin infection in the site of catheter insertion; Stability of vital signs according to the opinion of Neonatologist &#13;
Exclusion criteria:&#13;
All contraindications for PICC insertion (coagulopathy;  venous thrombosis; generalized skin disorders or skin infection in the site of catheter insertion; Transport the neonate to another  medical centres.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>1 year</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>p07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Birth weitht between 1000-2499 grams</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After  randomization in two paralel groups , UVC will  remove and a PICC will  place at 3-7 days after birth in one group of the study . Using sterile technique, one specially trained neonatal nurse with cooperation of Neonatology fellowship will  place the PICCs.Catheters made by Vygon company with  2 French caliber  with breakable introducer needles will use. Three betadine swabs, with at least 1 min drying time for each, will be  use when placing the PICCs.  All PICCs will  place in the upper limbs; placement of these lines will  confirme at T4 to T6 level  by radiograph.  Trained nurses are   responsible for changing the PICC dressings.  The PICCs will monitore daily to ensure that the PICC dressing is  occlusive.  when necessary, the dressing will change.</i_keyword>
      <i_keyword>In  the other group after removing UVC with a   clean technique, place the peripheral IV lines.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Catheter-related bloodstream infection. Timepoint: From cathrter insertion time to discharge from hospital. Method of measurement: With clinical symptom and paraclinical evidences specially blood culture.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mortality rate. Timepoint: From the admition until death time. Method of measurement: according to pationt dosseir.</sec_outcome>
      <sec_outcome>Hospital stay duration. Timepoint: Hospitaization days from admition until discharge or death. Method of measurement: accoding to dossier data.</sec_outcome>
      <sec_outcome>Local complication such as skin infection. Timepoint: From insertion untill remove of catether. Method of measurement: Observation by nursing staff.</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>Pediatric health research  center of Tabriz university of medical sceinces</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-07-02</approval_date>
        <contact_name>Ethics commitee of Tabriz university of medical sceinces</contact_name>
        <contact_address>Tabriz Golgasht street. Medical University Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
