<?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>IRCT20170614034526N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-26</date_registration>
      <primary_sponsor>Children Hospital and institute of Child Health</primary_sponsor>
      <public_title>Comparison of  clinical efficacy   and  safety  of injectable  Levetiracetam  versus   Phenytoin</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of  clinical efficacy   and  safety  of injectable  Levetiracetam  versus   Phenytoin as second line  drug  in  the management  of generalized convulsive status epilepticus  in  children: An open label randomized control trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-01-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>650</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33671</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Children were divided into two groups by random allocation for the selection of second-line drug. Children received Levetiracetam were assigned as group A (LEV group) and those received phenytoins were assigned as group B (PHT group).
Sealed envelope system was used for randomization. A set of envelopes were prepared, each bearing the name of the drug (Phenytoin and Levetiracetam were written on 300 envelopes each) on it. All envelops were sealed properly and shuffled by a person not involved in the study. These pre-written, drug named sealed envelopes were opened at the time of administration of the second-line drug for the management of CSE.</study_design>
      <phase>4</phase>
      <hc_freetext>Generalized convulsive status epileptics..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A: Levetiracetam 40mg/kg infused in 15 minutes. Intervention 2: Control group: Group B: Phenytoin 20 mg/kg infused in 30minutes.</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 To keep the confidentiality of the study participants, however, data would be made available to the Ethics Committee of the institute upon requirement</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Nuzhat Noureen</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sher Shah Rd, Nawa Shehar, Mohalla Qadirabad,</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>60000</zip>
        <telephone>+92 61 9201431</telephone>
        <email>drnuzhatrana@gmail.com</email>
        <affiliation>Children Hospital and institute of Child Health</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Nuzhat Noureen</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sher Shah Rd, Nawa Shehar, Mohalla Qadirabad,</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>60000</zip>
        <telephone>+92 61 9201431</telephone>
        <email>drnuzhatrana@gmail.com</email>
        <affiliation>Children hospital and institute of child health</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male and Female Patients aged one to 14 years.
Patients with generalized convulsive status epilepticus, not responding to two doses of diazepam (0.2 mg/kg) given 5 minutes apart.
Parents /guardians of children willing to give Written informed consent.</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>14 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children received anticonvulsant treatment other than benzodiazepine for the acute management of CSE.
Children on assisted ventilation
Children with CSE secondary to hypertensive encephalopathy, head injury, chronic kidney or liver disease and electrolyte derangement (hypoglycemia, hypocalcaemia, hypo/hypernatremia, hypomagnesaemia)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G41.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other status epilepticus</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>Intervention group: Group A: Levetiracetam 40mg/kg infused in 15 minutes</i_keyword>
      <i_keyword>Control group: Group B: Phenytoin 20 mg/kg infused in 30minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Efficacy: cessation of seizures. Timepoint: within 30 minutes of administration. Method of measurement: Visual Inspection.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Safety: •	Respiratory depression •	Cardiac depression •	Hypotension •	Central nervous system (CNS) depression. Timepoint: From administration of study drug till the patient under monitoring for acute condition. Method of measurement: Monitoring was done by base line arterial blood gases, electrocardiogram, blood pressure and Glasgow coma scale.</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>Children Hospital and institute of Child Health</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-01-25</approval_date>
        <contact_name>Ethical committee of Children Hospital and institute of Child Health, Multan.</contact_name>
        <contact_address>Sher Shah Rd, Nawa Shehar, Mohalla Qadirabad, Multan Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
