<?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>IRCT2017041633471N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-09-27</date_registration>
      <primary_sponsor>Vice chancellor for research,Arak University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of prone and supine positions on arterial blood oxygen saturation and vital signs of premature newborn</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of prone and supine positions on arterial blood oxygen saturation and vital signs of premature newborn</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>22</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25799</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Other design features: In this study, after selecting the samples based on inclusion criteria, the samples will be placed in the two intervention and control groups with paired block randomization.  In addition to arterial blood oxygen concentration, at the same time premature newborns` vital signs such as respiratory rate, heart rate and body temperature will be monitored and documented.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sleep state to the abdomen and back.</hc_freetext>
      <i_freetext>Intervention 1: Second Intervention:sleep newborn on supine position for 3 hours. Intervention 2: First intervention: Sleep newborn on prone position for 3 hours.</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>Ali Arash Anoshiravani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Deputy of research and technology,Third Floor,Imam Musa Kazim Building,Academic Complex of the Payamber ,  Basij Square,Arak;Markazi Province</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 86 3417 3638</telephone>
        <email>Research@arakmu.ac.ir</email>
        <affiliation>Vice chancellor for research,Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Doc  Sharareh khosravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Blue Bal,School of Nursing and Midwifery , Academic Complex of Prophet Muhammad (PBUH, Sardasht, Basij Sq, Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 86 3417 3503</telephone>
        <email>shararehkh2011@yahoo.com</email>
        <affiliation>Faculty of Nursing and Midwifery, Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: gestational age between 32-36 weeks; birth age of 2 days to 4 weeks; weight at least 1000 grams; not using ventilator; spontaneous breathing; maximum oxygen concentration of 5 liter/minute if using oxygen by hood or incubator; free of congenital anomalies, free of active bleeding; not having blood problems; methemoglobinemia; carboxyhemoglobinemia; hemoglobin greater than 9 gr/dl; not using narcotics, corticosteroids, and surfactant&#13;
&#13;
Exclusion criteria: connecting to ventilator; infecting with pneumothorax; death; parental dissatisfaction with continuing the work; need to perform CPR</inclusion_criteria>
      <agemin>2 days</agemin>
      <agemax>1 month</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Second Intervention:sleep newborn on supine position for 3 hours</i_keyword>
      <i_keyword>First intervention: Sleep newborn on prone position for 3 hours</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Arterial Blood Oxygen Saturation. Timepoint: Every 15 minutes to 3 Hours. Method of measurement: Puls Oximiter.</prim_outcome>
      <prim_outcome>Heart Rate. Timepoint: Every 15 minutes to 3 hours. Method of measurement: Puls Oximiter.</prim_outcome>
      <prim_outcome>Breath Rate. Timepoint: Every 15 minutes to 3 hours. Method of measurement: Chest lead.</prim_outcome>
      <prim_outcome>Temperature. Timepoint: Every 15 minutes to 3 hours. Method of measurement: SkinThermometer.</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>Vice chancellor for research,Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-03-13</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Deputy of research and technology;Third Floor;Imam Musa Kazim Building;Academic Complex of the Payamber ;  Basij Square;Arak;Markazi Province Arak  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
