<?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>IRCT20211015052778N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-11</date_registration>
      <primary_sponsor>Boushehr University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of phototherapy on premature neonates</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of prophylactic phototherapy with therapeutic phototherapy on serum bilirubin and neurodevelopment in 1500-2000-gr preterm neonates</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59423</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Infants with ≤1500-2000 gr will be randomly divided into two groups. 
Random allocation was performed using R software and the resulting random design will be placed in special envelopes. Infants who meet the required criteria will be assigned to the intervention group (A) and the control group (B) consecutively. The random allocation file is attached in the appendices section. The intervening physician will not be aware of the random allocation scheme and the number of blocks, Blinding description: Study participants do not know whether they are in the control or the intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hyperbilirubinemia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: infants will receive prophylactic phototherapy in the first 24 hours after birth. Phototherapy will be performed using a 5-DTA-lamp portable Phototherapy Equipment - XHZ-90P with Philips lamps in Shohadaye Khalije Fars Hospital and using Tucson phototherapy device with Philips lamps in Social Security Hospital (Salman Farsi Hospital). Intervention 2: Control group: receive no prophylaxis, and infants will receive theraputic phototherapy after bilirubin rise according to the curves in Nelson's book.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Due to possible use by ourselves for future projects</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soroush Ostadzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sina Dormitory, Hafez Ave., Taleghani Blvd</address>
        <city>Boushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7514665936</zip>
        <telephone>+98 77 3333 5250</telephone>
        <email>soorena767@gmail.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeede Firoozbakht</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sangi street</address>
        <city>Boushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۵۱۷۹۳۳۷۵۵</zip>
        <telephone>+98 77 3345 5375</telephone>
        <email>s.firouzbakht@bpums.ac.ir</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Premature infants weighing 1500-2000 gr</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>4 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissatisfaction with participating in the study
Asphyxia
Cerebral hemorrhage
Meningitis
Neurological problems such as seizures without jaundice
Structural brain problems
Hypoxia
Sepsis (positive blood culture)
ABO incompatibility
First-day jaundice</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E80.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other disorders of bilirubin metabolism</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: infants will receive prophylactic phototherapy in the first 24 hours after birth. Phototherapy will be performed using a 5-DTA-lamp portable Phototherapy Equipment - XHZ-90P with Philips lamps in Shohadaye Khalije Fars Hospital and using Tucson phototherapy device with Philips lamps in Social Security Hospital (Salman Farsi Hospital)</i_keyword>
      <i_keyword>Control group: receive no prophylaxis, and infants will receive theraputic phototherapy after bilirubin rise according to the curves in Nelson's book.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total bilirubin. Timepoint: Measurement of total blood bilirubin at the beginning of the study (before the intervention) and then on days 1, 3, 5, 7 and 10 after birth. Method of measurement: In Shohadaye Khalije Fars Hospital, the bilirubin samples will be tested based on photometric principles and using Jendrssik Grof Assay kit from Biorex Fars Company through DIRUI CS-400 Auto-Chemistry Analyzer. In Salman Farsi Hospital, the bilirubin samples will be measured based on the same principles and kit used in the Shohadaye Khalije Fars Hospital using the DIRUI CS-400 Auto-Chemistry Analyzer.</prim_outcome>
      <prim_outcome>Development. Timepoint: 2 and 4 month. Method of measurement: By ASQ questionnaire.</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>Boushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-19</approval_date>
        <contact_name>Ethics committee of Boushehr University of Medical Sciences</contact_name>
        <contact_address>Bushehr University of Medical Sciences and Health Services, In front of Mosallaye Namaze Jome, Moallem St. Boushehr Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
