<?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>IRCT201108117295N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-02-16</date_registration>
      <primary_sponsor>Vice chancellor for research, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The role of insulin therapy in reducing critical illness polyneuropathy and myopathy in pediatric intensive care unit</public_title>
      <acronym></acronym>
      <scientific_title>The role of insulin therapy in reducing critical illness polyneuropathy and myopathy in pediatric intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7743</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>polyneuropathy and myopathy.</hc_freetext>
      <i_freetext>Intervention 1: In this study,during one year and a half,30 of patients admitted to the pediatric intensive care unit of Tabriz Children's Hospital and are more than one week under mechanical ventilation and in the course of their hospitalization experience hyperglycemia (more than 180 milligram per decilitre) are divided into two groups; In first group with 15 patients,in which the intervention is done, insulin is used in order to keep blood sugar in range of 140-180 milligram per decilitre (until the patient is connected to the ventilator).Appropriate protocol will be continuous injection of 0.5 unit per kilogram insulin as drip with serial control of blood sugar each hour with the goal of keeping blood sugar between&#13;
140-180 milligram per decilitre. Note that the injection  will be as same as first group and will be done by a person with no information about polymyopathy and neuropathy. Intervention 2: In second group with 15 patients which is called control group,distilled water as placebo will be used.Appropriate protocol in using distilled water,like insulin injection in intervened group,is continuous injection of 0.5 unit per kilogram insulin as drip with serial control of blood sugar each hour.Note that the injection will be done by a person with no information about polyneuropathy and myopathy and the injected substance.</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>Shahram Sadegvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>34 number, Amirkabir Avenue, Shahrak Baghmishe, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5155997434</zip>
        <telephone>+98 41 1668 0691</telephone>
        <email>shahramsharar@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nemat Bilan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Children's Hospital, Sheshgalan Avenue, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5136735886</zip>
        <telephone>+98 41 1526 2280</telephone>
        <email>bilan@tbzmed.ac.ir</email>
        <affiliation>Tabriz Univercity of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria and who are under investigation in this study are the following:&#13;
In this study,during one year and a half,30 of patients admitted to the pediatric intensive care unit of Tabriz Children's Hospital and are more than one week under mechanical ventilation and in the course of their hospitalization experience hyperglycemia (more than 180 milligram per decilitre) are divided into two groups; In first group with 15 patient insulin is used in order to keep blood sugar in range of 140-180 milligram per decilitre (until the patient is connected to the ventilator); In second group with 15 patient,distilled water as placebo will be used (Note that injection will be done by a person who has no information about the polyneuropathy and myopathy).&#13;
Confounding variables are important in this study and the following people are excluded from study; spinal cord injuries; patients with Guillain Barre Syndrome;  myasthenia gravis; patients with central nervous system problems or neuromuscular disease causing  muscle weakness and paralysis&#13;
 before or during the hospitalization; hypophosphatemia.&#13;
Appropriate methods to control confounding variables are according to  observation,periods of physical examination,laboratory results such as blood and cerebro spinal fluid tests and  EMG and NCV. It should be noted that the removal of these patients are so that in each point of the study (before the start of or during the study) if each of 5 problems above found by methods such as Electromygraphy and testing of cerebrospinal fluid or physical examination period,the patient will be excluded.</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>14 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10,E11.E1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetic polyneuropathy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study,during one year and a half,30 of patients admitted to the pediatric intensive care unit of Tabriz Children's Hospital and are more than one week under mechanical ventilation and in the course of their hospitalization experience hyperglycemia (more than 180 milligram per decilitre) are divided into two groups; In first group with 15 patients,in which the intervention is done, insulin is used in order to keep blood sugar in range of 140-180 milligram per decilitre (until the patient is connected to the ventilator).Appropriate protocol will be continuous injection of 0.5 unit per kilogram insulin as drip with serial control of blood sugar each hour with the goal of keeping blood sugar between&#13;
140-180 milligram per decilitre. Note that the injection  will be as same as first group and will be done by a person with no information about polymyopathy and neuropathy.</i_keyword>
      <i_keyword>In second group with 15 patients which is called control group,distilled water as placebo will be used.Appropriate protocol in using distilled water,like insulin injection in intervened group,is continuous injection of 0.5 unit per kilogram insulin as drip with serial control of blood sugar each hour.Note that the injection will be done by a person with no information about polyneuropathy and myopathy and the injected substance.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood glucose. Timepoint: Serial monitoring of blood glucose per hour (the aim of maintaining blood glucose range  140-180 milligram per decilitre). Method of measurement: Glucometry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Polyneuropathy and myopathy. Timepoint: After extubation. Method of measurement: Electromyography.</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, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-06-06</approval_date>
        <contact_name>The ethics committee of Tabriz University of Medical Sciences, Faculty of Medicine</contact_name>
        <contact_address>Faculty of Medicine,  Tabriz University of Medical   Sciences, Golgasht Avenue, Tabriz Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
