<?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>IRCT2017061018974N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-07-25</date_registration>
      <primary_sponsor>Deputy Minister for Research and Technology</primary_sponsor>
      <public_title>Evaluation of probiotics effects on bilirubin level</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of probiotics effects on bilirubin level in patient with neonatal jaundice admitted in the hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17089</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>1</phase>
      <hc_freetext>neonatal hyperbilirubinemia.</hc_freetext>
      <i_freetext>Intervention 1: Infants in the study group(treated)receive,about 5 drops probiotics 3 times a day + phototherapy&#13;
probiotic is included Lactobacillus rhamnosus &#13;
- Lactobacillus reuteri&#13;
- Bifidobacterium infanti.&#13;
 Drops are produced in Iran by iran Takhmer company, and are licensed in England&#13;
conventional  photitherapy :6 lamp photo mark  PHilips TL 20/120 made in germany in 35 cm from patient. Intervention 2: control group:  Distilled water 5 drops/3 times day+phototherapy   Distilled waters are produced by shahid ghazi in 2 cc package    conventional phototherapy :6 lamp photo mark PHilips TL 20/120 made in Germany in 35 cm from patient.</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>simin gheini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mohamad kermanshahi Hospital</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 3721 8204</telephone>
        <email>simingheini@yahoo.coms.gheini@kums.ac.ir</email>
        <affiliation>kermanshah university of medical sceinces</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>simin gheini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mohamad kermanshahi Hospital</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 912 348 5142</telephone>
        <email>simingheini@yahoo.coms.gheini@kums.ac.ir</email>
        <affiliation>kermanshah university of medical sceinces</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: term infants with  age between 3-10 days and gestational age of 42-37 weeks , birth weight equals or more than 2500 g , and  bilirubin 12.9-up mg / dL  at the start of phototherapy, and fed only by breast milk.Exclusion criteria: infants with blood disorders family, having signs of hemolysis due to blood group incompatibility, internal bleeding indoors due to complications of traumatic birth (exp : cephalohematom), suspected neonatal infection such as chorioamnionitis, intrauterine infection, sepsis and urinary tract infection, perinatal hypoxic newborns, having thyroid dysfunction, distress or respiratory failure, malfunction regulate body temperature and metabolic, hemodynamic instability and congenital heart disease, a history of maternal use of phenobarbital during the last month of pregnancy venous hematocrit 65%</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>10 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P59.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>P59.9 Neonatal jaundice, unspecified Physiological jaundice (intense)(prolonged) NOS</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>Infants in the study group(treated)receive,about 5 drops probiotics 3 times a day + phototherapy&#13;
probiotic is included Lactobacillus rhamnosus &#13;
- Lactobacillus reuteri&#13;
- Bifidobacterium infanti.&#13;
 Drops are produced in Iran by iran Takhmer company, and are licensed in England&#13;
conventional  photitherapy :6 lamp photo mark  PHilips TL 20/120 made in germany in 35 cm from patient.</i_keyword>
      <i_keyword>control group:  Distilled water 5 drops/3 times day+phototherapy   Distilled waters are produced by shahid ghazi in 2 cc package    conventional phototherapy :6 lamp photo mark PHilips TL 20/120 made in Germany in 35 cm from patient</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bilirubin level. Timepoint: from 1 to 4 days. Method of measurement: serum lilirubin level.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Defecations times. Timepoint: 1 and 4 days. Method of measurement: mother report.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>no</sec_id>
        <issuing_authority>no</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Deputy Minister for Research and Technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-05-17</approval_date>
        <contact_name>Ethics Committee kermanshah university of medical sceinces</contact_name>
        <contact_address>kermanshah shahid behashti Blv number 2 building kermanshah  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
