<?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>IRCT20100607004113N18</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-18</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Palliative Care protocol on mortality and morbidity of Extremely Low Birth Weight Infants</public_title>
      <acronym></acronym>
      <scientific_title>Early outcome of Extremely Low Birth Weight Infants before and after Establishment of Palliative Care protocol  according to Clinical Risk Index for Babies scoring system (CRIB II)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38963</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Blinding description: research nurse who are blinded to groups  . Analyzer  of the data  also will be blind to the groups of infants.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Extreme immaturity of newborn.</hc_freetext>
      <i_freetext>Intervention 1: Preterm infants in two parallel groups include in the non randomized  study , Intervention group are infants who have score of 15 or more according to Clinical Risk Index for Babies scoring system (CRIB II)  .After consent of the parents This group of patients  will receive palliative care consist of :thermal stabilization ,respiratory support  as  Nasal Continues Positive Airway Pressure  , use of intravenous  antibiotics consist of Ampicillin and Gentamicin( according to the guideline of the unit) and Total Parenteral Nutrition. Intervention 2: Control group: are preterm  infants who have score of  less than 15 according ( CRIB II )scoring system  .This group of infants will receive full support  care consist of : thermal stabilization ,respiratory support  as  Nasal Continues Positive Airway Pressure and  Mechanical ventilation if needed  , use of intravenous  antibiotics consist of Ampicillin and Gentamicin( according to the guideline of the unit) , Total Parenteral Nutrition and Surfactant therapy.</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 This study is in the first steps and may be repeated in other centers without ethical considerations</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammadbagher Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Artesh Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138663134</zip>
        <telephone>+98 41 3553 9161</telephone>
        <email>hosseini.neo@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadbagher Hosseini MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Artesh street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138663134</zip>
        <telephone>+98 41 3553 9161</telephone>
        <email>hosseini.neo@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Extremely Low Birth Weight preterm infants with  gestational age of  ( 24 weeks+0 Day) to ( 26 weeks+6 Days)
Birth weight between  500- 750 grams
Inborn and admitted in Neonatal Intensive Care Unit of Alzahra teaching hospital of Tabriz</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>1 day</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Born after  assisted reproductive technology or In vitro fertilization (IVF)
Infants born  with major anomalies or birth defects
Gestational age less than 24 Weeks or more than 27 weeks  of gestation
Infants who's parents aren't  agreed with palliative care</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Preterm infants in two parallel groups include in the non randomized  study , Intervention group are infants who have score of 15 or more according to Clinical Risk Index for Babies scoring system (CRIB II)  .After consent of the parents This group of patients  will receive palliative care consist of :thermal stabilization ,respiratory support  as  Nasal Continues Positive Airway Pressure  , use of intravenous  antibiotics consist of Ampicillin and Gentamicin( according to the guideline of the unit) and Total Parenteral Nutrition.</i_keyword>
      <i_keyword>Control group: are preterm  infants who have score of  less than 15 according ( CRIB II )scoring system  .This group of infants will receive full support  care consist of : thermal stabilization ,respiratory support  as  Nasal Continues Positive Airway Pressure and  Mechanical ventilation if needed  , use of intravenous  antibiotics consist of Ampicillin and Gentamicin( according to the guideline of the unit) , Total Parenteral Nutrition and Surfactant therapy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mortality of ELBW neonate before and after Establishment of palliative care  protocol according to   (CRIB II) scoring system. Timepoint: From birth to discharge from hospital  or death. Method of measurement: Questioner and evaluation of vital sign.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Necrotizing enterocolitis (NEC) satge 2 or more. Timepoint: From birth until discharge from hospital. Method of measurement: Questioner and Bell's stage.</sec_outcome>
      <sec_outcome>Retinopathy  of Prematurity need intervention ( Photocoagulation or Evastin injection ). Timepoint: From 28 days after birth until discharge from hospital. Method of measurement: Questioner and  Revised International Classification of ROP (ICROP).</sec_outcome>
      <sec_outcome>Intraventricular Hemorrhage Grade 2 or more. Timepoint: During first week of life. Method of measurement: Brain ultrasonography.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-07</approval_date>
        <contact_name>Ethics commitee of Tabriz University of Medical Sceinces</contact_name>
        <contact_address>Golgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
