<?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>IRCT20170922036321N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-02</date_registration>
      <primary_sponsor>Vice chancellor for research, Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>The effect of reducing light bulb distance in reducing jaundice in newborns with jaundic</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy and complication the distance phototherapy lamps of the surface body infant with jaundice</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27188</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: newborn had entry criteria were parallel assigned two groups of control and intervention after being satisfied with their parents, Blinding description: The experimenter did not know which sample is in the intervention group and which sample is in the control group?.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Jaundice.</hc_freetext>
      <i_freetext>Intervention 1: The control group was treated with phototherapy at a distance of 45 cm from the body surface of the newborn's body. Intervention 2: Intervention group: This group was treated with phototherapy at a distance of 20 cm from the body surface of the newborn's body.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Parvin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sabzevar University of Medical Sciences</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0098519613873136</zip>
        <telephone>+98 51 4401 1300</telephone>
        <email>parvinf1@mums.ac.ir</email>
        <affiliation>Mrs Roghayeh Zardosht</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Parvin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Campus Complex of Sabzevar Medical University,Tohid boulvard, Sabzevar.</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0098519613873136</zip>
        <telephone>+98 51 4401 1300</telephone>
        <email>Parvinf1@mums.ac.ir</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Term neonate(gestational age &gt;32 weeks) with weight more than 2000 grams; No congenital anomalies؛ No congenital infections; Normal suking reflux;neonate after 24 hours had diuresis and defication; Bilirubin serum in the second day (10-15 mg/dl), third day (13-17 mg/dl), fourth day (14-15 mg/dl),fifth to seventh days (15-18 mg/dl) seventh days and more (18-20 mg/dl)l; there is no indication of Rh incompatibility.
weight more than 2000 grams
No congenital anomalies؛
No congenital infections
Normal suking reflux
neonate after 24 hours had diuresis and defication
neonate age older than 24 hours
Bilirubin serum in the second day (10-15 mg/dl), third day (13-17 mg/dl), fourth day (14-15 mg/dl),fifth to seventh days (15-18 mg/dl) seventh days and more (18-20 mg/dl)
there is no indication of Rh incompatibility</inclusion_criteria>
      <agemin>2 days</agemin>
      <agemax>21 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Parental withdrawal from continuing research with infants
infected during the study
Patient's need for blood transfusion
Patient's need for IVIG
jaundice due to the following causes; G6PD deficiency and hypothyroidism; and Rh and ABO incompatibility; and evidence of hemolysis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>p59</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neonatal jaundice, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The control group was treated with phototherapy at a distance of 45 cm from the body surface of the newborn's body.</i_keyword>
      <i_keyword>Intervention group: This group was treated with phototherapy at a distance of 20 cm from the body surface of the newborn's body</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Neonatal blood serum Bilirubin. Timepoint: At the reception, 12 hours and 24 hours after the start of phototherapy. Method of measurement: Neonatal venous blood sampling.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Baby body temperature. Timepoint: Every 6 hours. Method of measurement: thermometer.</sec_outcome>
      <sec_outcome>Skin rash. Timepoint: Every 8 hours. Method of measurement: Abservation.</sec_outcome>
      <sec_outcome>Weight Loss. Timepoint: Daily. Method of measurement: Daily weighing.</sec_outcome>
      <sec_outcome>Incidence of loose stools. Timepoint: Every 8 hours. Method of measurement: Abservation.</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, Sabzevar University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-01</approval_date>
        <contact_name>Vice chancellor for research, Sabzevar University of Medical Sciences</contact_name>
        <contact_address>Campus Complex of Sabzevar Medical University,Tohidl levard, Sabzevar. Sabzeva Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
