<?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>IRCT2015032621542N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-08-23</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>The effects of prone positions on o2 saturation and heart rate in ventilated premature infants</public_title>
      <acronym></acronym>
      <scientific_title>The effects of prone positions on o2 saturation and heart rate in ventilated premature infants</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-07-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>35</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18853</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Respiratory and cardiovascular disorders specific to the perinatal period.</hc_freetext>
      <i_freetext>Thirty five cases of low birth weight infants ( birth weight less than 2000 g ) and premature ( less than 34 weeks gestational age ) located under mechanical ventilation , Inclusion Entry criteria infants under mechanical ventilation for 2 hours supine position and physiological parameters recorded during this period every 10 minutes and the infant placed prone position for 2 hours During this time physiological parameters in 10 minutes by monitoring cardiac -inspiratory ( monitoring  SAADAT ) measured by pulse oximeter and recorded and compared with the mean in each state.</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>Tahereh Babuyeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol University of Medical Sciences, Ganjafrooz st.</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4775447-976</zip>
        <telephone>+98 119832238301</telephone>
        <email>t.babuyeh@yahoo.com; t.babuyeh@mu.babol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahereh Babuyeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol University of Medical Sciences, Ganjafrooz st.</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4775447-976</zip>
        <telephone>+98 11 3223 8301</telephone>
        <email>t.babuyeh@yahoo.com; t.babuyeh@mu.babol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: infants mechanical ventilated premature newborns; less than 34 weeks of pregnancy; weighing less than 2000 grams. Exclusion criteria: non mechanical ventilated infants and mechanical ventilated infants over 34 weeks of pregnancy and weight more than 2000 grams; infants with congenital anomalies; under mechanical ventilation for less than 4 hours; recent receive sedation drugs; infants with umbilical vein catheters and umbilical artery catheters and chest tubes; infants during the first 4 hours of mechanical ventilation are complications such as pneumothorax.</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>28 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P20-29</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Respiratory and cardiovascular disorders specific to the perinatal period</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Thirty five cases of low birth weight infants ( birth weight less than 2000 g ) and premature ( less than 34 weeks gestational age ) located under mechanical ventilation , Inclusion Entry criteria infants under mechanical ventilation for 2 hours supine position and physiological parameters recorded during this period every 10 minutes and the infant placed prone position for 2 hours During this time physiological parameters in 10 minutes by monitoring cardiac -inspiratory ( monitoring  SAADAT ) measured by pulse oximeter and recorded and compared with the mean in each state</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>O2 saturation. Timepoint: Every ten minutes during two hours while studying and sleeping in the supine position the abdomen position. Method of measurement: Pulsoxymeter.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Every ten minutes during two hours while studying and sleeping in the supine position the abdomen position. Method of measurement: Pulsoxymeter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Bradycardia. Timepoint: Every ten minutes during two hours while studying and. Method of measurement: Pulsoxymeter.</sec_outcome>
      <sec_outcome>Tachycardia. Timepoint: Every ten minutes during two hours while studying and. Method of measurement: Pulsoxymeter.</sec_outcome>
      <sec_outcome>Reduced blood arterial oxygen saturation. Timepoint: Every ten minutes during two hours while studying and                                                                                                                                                                                                                                                                               Reduced blood arterial oxygen saturation                                                                                                                                                                                                                                                                                  Reduced blood arterial oxygen saturation                                                                                                                                                                                                            Reduced blood arterial oxygen saturation                                                                                                                                                                                reduced blood arterial oxygen saturation. Method of measurement: Pulsoxymeter.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-08-02</approval_date>
        <contact_name>Babol University of Medical Sciences</contact_name>
        <contact_address>Babol University of Medical Sciences, Ganjafrooz st. Babol  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
