<?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>IRCT201204078315N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-05-13</date_registration>
      <primary_sponsor>Research Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of endotracheal suctioning on clinical outcomes in preterm neonates</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of two methods open and closed endotracheal suctioning on clinical outcomes in preterm neonates in NICUs of Alzahra and Taleghani Teaching Hospitals, Tabriz, 2012</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-05-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8761</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>1</phase>
      <hc_freetext>Evaluation of suction effect.</hc_freetext>
      <i_freetext>Intervention 1: In closed group tracheal sactioning will be continued for atlleast48 huors. BP,HR,O2SAT should be recorded one minute before and one and five minutes after procedure,How ever frequency of suctioning and side effects as polmunary hemorage, IVH, penomotorax, ponomonia and septisemy until extubation and as well as duration of hospitalization registered in the special data forms . Intervention 2: In open  group tracheal sactioning will be continued for atlleast48 huors. BP,HR,O2SAT should be recorded one minute before and one and five minutes after procedure,How ever frequency of suctioning and side effects as polmunary hemorage, IVH, penomotorax, ponomonia and septisemy until extubation and as well as duration of hospitalization registered in the special data forms .</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>rahele janani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz Faculty of Nursing and Midwifery,South Shariati Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00984114796770</zip>
        <telephone>+98 41 1328 0465</telephone>
        <email>rahele_janani@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Leila Valizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz Faculty of Nursing and Midwifery,South Shariati Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1479 6770</telephone>
        <email>valizadehl@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1- Preterm neonates of 27-34 weeks of gestational age born at Alzahra and Taleghani hospitals whom are admitted at NICU. 2- After maximum 24 hours of their admission to NICU are intubated due to the respiratory distress. 3- Neonates receiving surfactant. 4- Preterm neonates who are ventilated for at least 48 hours. 5- Neonates without congenital anomalies or heart diseases. 6- Neonates without MAS. 7- PROM less than 18 hours  and 8-  Neonates with less than 3 times of intubation trial.&#13;
Exclusion criteria: 1- Neonates with proved immune deficiency. 2- Neonates who are referred to other centers before completion of data and 3-  Neonates whose congenital heart disease and ... is verified later.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>10 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J70.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Respiratory conditions due to unspecified external agent</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In closed group tracheal sactioning will be continued for atlleast48 huors. BP,HR,O2SAT should be recorded one minute before and one and five minutes after procedure,How ever frequency of suctioning and side effects as polmunary hemorage, IVH, penomotorax, ponomonia and septisemy until extubation and as well as duration of hospitalization registered in the special data forms .</i_keyword>
      <i_keyword>In open  group tracheal sactioning will be continued for atlleast48 huors. BP,HR,O2SAT should be recorded one minute before and one and five minutes after procedure,How ever frequency of suctioning and side effects as polmunary hemorage, IVH, penomotorax, ponomonia and septisemy until extubation and as well as duration of hospitalization registered in the special data forms .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Verification and comparison of physiological stability. Timepoint: Befor one minute and after one minute and after five minute. Method of measurement: By the use of  Monitoring.</prim_outcome>
      <prim_outcome>Number of suctioning needed. Timepoint: Duration of time from first suctioning till extubation. Method of measurement: Data record form.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration  of  hospitalization. Timepoint: Untill discharch from NICU. Method of measurement: Data record form.</sec_outcome>
      <sec_outcome>Side effects of suctioning. Timepoint: From 24 after first suctioning till extubation. Method of measurement: By use of data record form.</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>Research Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-03-12</approval_date>
        <contact_name>Tabriz Medical Sciences Ethic Committee</contact_name>
        <contact_address>Golgasht St.Tabriz University of Medical Sciences Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
