<?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>IRCT2012123010279N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-01-12</date_registration>
      <primary_sponsor>Health Ministry Drug and Pharmacy General Management</primary_sponsor>
      <public_title>Saccharomyces boulardii's efficiency on hyperbilirubinemia</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the efficiency of Saccharomyces boulardii on neonatal hyperbilirubinemia with placebo on late pereterm and term neonates</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-07-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10742</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients were assigned randomly to the study or control group by the principal investigator. Randomization was performed by using sequential numbers generated at the computer center. One nurse who was not involved in the care of the infants prepared Saccharomyces boulardii or distilled water. She gave the prepared material without label to the nurse who was responsible for the infant’s care. The first investigator who randomized patients and ordered supplementation to the first nurse gave just only the patients' name to the second investigator for follow-up. Therefore, the only personnel who knew the infants’ group assignments were the first investigator and the first nurse, who were not involved in the care of the study infants.</study_design>
      <phase>3</phase>
      <hc_freetext>Neonatal hyperbilirubinemia.</hc_freetext>
      <i_freetext>Intervention 1: The study group received Saccharomyces boulardii (Reflor®, Biocodex, France, 50 mg/kg per dose twice daily) during phototherapy. Intervention 2: The control group received placebo (distilled water; 1 cc per dose twice daily) during phototherapy.</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>Fahri Ovali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No:3-4 , Dr.Burhanettin Üstünel Sokak, Zeynep Kamil Mahallesi,</address>
        <city>Istanbul</city>
        <country1>Turkey</country1>
        <zip>34668</zip>
        <telephone>80 06 391 216 90 00</telephone>
        <email>fovali@yahoo.com</email>
        <affiliation>Zeynep Kamil Maternity and Children Education and Training Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Guner Karatekin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No:3-4,  Dr.Burhanettin Üstünel Sokak, Zeynep Kamil Mahallesi,</address>
        <city>Istanbul</city>
        <country1>Turkey</country1>
        <zip>34668</zip>
        <telephone>00 90 216 391 06 80</telephone>
        <email>gunerkaratekin@yahoo.com</email>
        <affiliation>Zeynep Kamil Maternity and Children Education and Training Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Turkey</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
1.	Late preterm (34, not completed week – 36, completed week) gestational weeks ) and term  (≥ 37 gestational weeks) neonates&#13;
2.    Newborns who need phototherapy for neonatal hyperbilirubinemia&#13;
3.    Newborns who were 0-1 month old.&#13;
&#13;
Exclusion criteria:&#13;
1.     Newborns who have congenital anomalies&#13;
2.     Newborns who need intense phototherapy&#13;
3.	Direct coombs positive ABO/Rh incompatability&#13;
4.	Neonates who have sepsis/pneumonia during phototherapy&#13;
5.	Neonates with hypothyroidism&#13;
6.	Neonates who have gastrointestinal obstruction&#13;
7.	Neonates with asphyxia&#13;
8.	Contraindication of peroral feeding</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>1 year</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P 59.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neonatal jaundice from breast milk inhibitor</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The study group received Saccharomyces boulardii (Reflor®, Biocodex, France, 50 mg/kg per dose twice daily) during phototherapy.</i_keyword>
      <i_keyword>The control group received placebo (distilled water; 1 cc per dose twice daily) during phototherapy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Phototherapy duration. Timepoint: Starts at the same time with the intervention. Method of measurement: Patients' medical records.</prim_outcome>
      <prim_outcome>Maximum bilirubinemia level. Timepoint: Starts at the same time with the intervention. Method of measurement: Patients' laboratory records.</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>Health Ministry Drug and Pharmacy General Management</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-07-20</approval_date>
        <contact_name>Zeynep Kamil Maternity and Children Education and Training Hospital Ethic Commitee</contact_name>
        <contact_address>No:3-4, Dr.Burhanettin Üstünel Sokak, Zeynep Kamil Mahallesi, Istanbul Uskudar Turkey</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
