<?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>IRCT201010285038N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-10-25</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of topical application of human milk ,chlorhexidinon on umbilical cord of newborn</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of topical application of human milk ,chlorhexidin and dry cord care on the cord-separation time and bacterial colonization of  cord of newborn</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-12-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>261</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5379</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Certain conditions originating in the perinatal period.</hc_freetext>
      <i_freetext>Intervention 1: Intervention GROUP:In group topical application of human milk of all mothers will be advised after washing hands with soap and water, she will rub its own milk to cord stump from three hours after birth every 12 hours (2 times a day) to 2 days after the umbilical cord  separation and allow the milk of the cord is completely dry. Intervention 2: Intervention GROUP:In group chlorhexidine mother will wet a cotton swab by placing it on the mouth of the chlorhexidine bottle 4% (30 ml bottle) and inverting the bottle. Then gently will rub the abdominal skin around the base and cord stump thoroughly, ensuring that the entire area was covered with solution. A second cotton swab will similarly moistened and used to cleanse the tip of the cord (if not yet separated) or the middle of the cord stump (if separation had occurred). she will rub its from three hours after birth every 12 hours (2 times a day) to 2 days after the umbilical cord  separation. Intervention 3: In group dry cord(control group ), mother will recommend that is not used any material on cord.</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>Fatemeh Abbaszadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th of Qotb –e Ravandi Blvd. P.O.Box: 87155.154, Kashan, IRAN</address>
        <city>kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 36 1555 0021</telephone>
        <email>abbaszadehs@yahoo.com</email>
        <affiliation>kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Abbaszadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th of Qotb –e Ravandi Blvd. P.O.Box: 87155.154, Kashan, IRAN</address>
        <city>kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 36 1555 0021</telephone>
        <email>abbaszadehs@yahoo.com</email>
        <affiliation>kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Criteria for Inclusion:&#13;
Newborns with gestational age 42-37 weeks; Apgar score higher than 7 at minute 1; rupture of membranes for no longer than 12 hours; The cord cut in sterile condition in the delivery room and  don't  use antiseptic agent on the stump.&#13;
&#13;
criteria for excluded:&#13;
Infants with perinatal asphyxia, respiratory distress, metabolic disease, and any other problems that requiring immediate refer to neonatal Intensive Care Unit ; Infants with immediate need of evaluation and treatment; Newborns with any congenital disorder or disease; Infants of mothers with postpartum fever, mastitis, Urogenital infection; If the mother does not live in the city of Kashan(live in Rural); If the mother is the Afghani.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>1 year</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P38</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Omphalitis of newborn with or without mild haemorrhage</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention GROUP:In group topical application of human milk of all mothers will be advised after washing hands with soap and water, she will rub its own milk to cord stump from three hours after birth every 12 hours (2 times a day) to 2 days after the umbilical cord  separation and allow the milk of the cord is completely dry</i_keyword>
      <i_keyword>Intervention GROUP:In group chlorhexidine mother will wet a cotton swab by placing it on the mouth of the chlorhexidine bottle 4% (30 ml bottle) and inverting the bottle. Then gently will rub the abdominal skin around the base and cord stump thoroughly, ensuring that the entire area was covered with solution. A second cotton swab will similarly moistened and used to cleanse the tip of the cord (if not yet separated) or the middle of the cord stump (if separation had occurred). she will rub its from three hours after birth every 12 hours (2 times a day) to 2 days after the umbilical cord  separation</i_keyword>
      <i_keyword>In group dry cord(control group ), mother will recommend that is not used any material on cord</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Umbilical cord  separation time. Timepoint: from birth to Cord separation time. Method of measurement: Researcher observed.</prim_outcome>
      <prim_outcome>Infection Umbilical cord. Timepoint: the first three hours after birth , days 3 and 7 after  intervention ,2 days after umbilical cord separation. Method of measurement: Culture of  samples.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Complications and problems such as leakage of blood, discharge and granuloma tissue. Timepoint: the first three hours after birth , days 3 and 7 after  intervention ,2 days after umbilical cord separation. Method of measurement: Observed by the researcher and  visited by neonatologist if there is any cord related adverse events.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-14</approval_date>
        <contact_name>Research Deputy of kashan University of Medical Sciences</contact_name>
        <contact_address>5th of Qotb –e Ravandi Blvd. P.O.Box: 87155.154, Kashan, IRAN kashan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
