<?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>IRCT201012295497N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-01-12</date_registration>
      <primary_sponsor>Vice chancellor for research, Hamedan University of Medical Sciences and Health Services</primary_sponsor>
      <public_title>Assessing the effect of serum therapy on decreasing of icterus</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Intravenous Fluid therapy on decreasing serum bilirubin during intensive phototherapy in healthy term neonate with severe non hemolytic hyperbilirubinemia in comparison with phototherapy alone</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5899</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Neonatal jaundice.</hc_freetext>
      <i_freetext>Intervention 1: One hundred sixty neonates  with hyperbilirubinemia who were admitted at neonate ward of Besat hospital of Hamedan, Iran and who are breast feeding were divided to two groups. Eighty neonates  in intervention group receive 70 cc per kg of ⅓-⅔serum daily with phototherapy (together) . The serum that was used, contains  sodium as ⅓of normal saline and glucose as of ⅔dextrose 5% and use this serum intravenous until total bilirubin being less than 17. This serum made in Tehran Darou Company. Intervention 2: One hundred sixty neonates with hyperbilirubinemia who were admitted at neonate ward of Besat hospital of Hamedan, Iran and who are breast feeding were divided to two groups. Eighty neonates (control) receive only phototherapy alone.</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>Abbas Moein</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamedan Besat Hospital</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 1264 0050</telephone>
        <email>a.moein@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical  Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbas Moein</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamedan  Besat Hospital</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 1264 0050</telephone>
        <email>a.moein@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical  Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:                                                                                              1.Term neonate (between 37 and 42 weeks of neonatal age ).                                                                   2. All neonates  between 2 and 28 days of  old age                                                                &#13;
  3. 17&lt; total serum bilirubin &lt;25 .                                                                               &#13;
 4. 2500 g &lt; weight&lt; 4000 g                                                                                        5. Without congenital anomaly and systemic diseases (sepsis, anemia, hemolysis, HMD).                                                                                                                 Exclusion criteria:                                                                                                        1. Neonate &lt;37 weeks of old age                                                                                   2. Congenital anomaly, systemic disease (sepsis, HMD. pneumonia, anemia, hemolysis)                                                                                                    3.Demand to blood exchange                                                                                                                  4. 4000 g &lt;Weight&lt; 2500 g .                                                                                     5. Neonates who in first ten days  of life loss more than 3% of weight.</inclusion_criteria>
      <agemin>2 years</agemin>
      <agemax>28 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P59</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neonatal jaundice from other and un specified causes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Early detection</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>One hundred sixty neonates  with hyperbilirubinemia who were admitted at neonate ward of Besat hospital of Hamedan, Iran and who are breast feeding were divided to two groups. Eighty neonates  in intervention group receive 70 cc per kg of ⅓-⅔serum daily with phototherapy (together) . The serum that was used, contains  sodium as ⅓of normal saline and glucose as of ⅔dextrose 5% and use this serum intravenous until total bilirubin being less than 17. This serum made in Tehran Darou Company.</i_keyword>
      <i_keyword>One hundred sixty neonates with hyperbilirubinemia who were admitted at neonate ward of Besat hospital of Hamedan, Iran and who are breast feeding were divided to two groups. Eighty neonates (control) receive only phototherapy alone.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Indirect bilirubin. Timepoint: During at 6, 12, 24, 48 and 72 hours after beginning of phototherapy. Method of measurement: Measuring serum bilirubin(diazo method).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Age. Timepoint: Between 2 and 28 days of  old age. Method of measurement: Since birthday.</sec_outcome>
      <sec_outcome>Duration of hospitalization. Timepoint: 6- 12- 24- 48 and 72 hours after phototherapy. Method of measurement: Hours.</sec_outcome>
      <sec_outcome>Sex. Timepoint: Beginning of study. Method of measurement: Physical examination.</sec_outcome>
      <sec_outcome>Blood group. Timepoint: Beginning of study. Method of measurement: Laboratory test.</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>Vice chancellor for research, Hamedan University of Medical Sciences and Health Services</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-05-14</approval_date>
        <contact_name>Ethics committee of Hamedan University of Medical Sciences and Health Services</contact_name>
        <contact_address>Opposite Mardom Park, Shahid Fahmide Ave, Mahdieh Ave, Hamedan Hamedan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
