<?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>IRCT20221105056406N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-26</date_registration>
      <primary_sponsor>Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of phenobarbital and levetiracetam in febrile seizures</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of phenobarbital and levetiracetam in children with febrile seizures</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66675</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization was used for randomization. sample allocation in the study was based on a random sequence provided by the statistics consultant(Table of random numbers).The sequence used was double blocks.</study_design>
      <phase>2</phase>
      <hc_freetext>Febrile convulsion(F.C).</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: The intervention method is a group of children aged 6 months to 60 months who have seizures caused by fever and have indications for drug therapy. Phenobarbital drug is given to this group in the amount of 3 to 5 mg per kilogram daily in two divided doses, and after 5 half-lives from the start of the drug (about 15 days), the serum level of the drug is measured by hplc method. And the number of convulsions and the intervals between convulsions and the side effects of the drug are checked before and after taking the drug. Intervention 2: Intervention group: The intervention method is a group of children aged 6 months to 60 months who have seizures caused by fever and have indications for drug therapy. In this drug group, levetiracetam is given at a dosage of 10 to 20 mg per kg twice a day. and after 5 half-lives from the start of the drug (about 15 days), the serum level of the drug is measured by hplc method. And the number of convulsions and the intervals between convulsions and the side effects of the drug are checked before and after taking the drug.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is It is not yet known if there will be a plan to make this available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parastoo Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohidshahr Blvd</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617913114</zip>
        <telephone>+98 51 4401 8319</telephone>
        <email>Amiri.Parasto@gmail.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kazem Hasan pour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Asadabadi Ave</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613873137</zip>
        <telephone>+98 51 4424 3465</telephone>
        <email>drhassanpour@yahoo.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 6 months to 60 months
Convulsions followed by fever</inclusion_criteria>
      <agemin>6 months</agemin>
      <agemax>60 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in the study
History of head trauma
Diseases of the central nervous system
Having diabetes
Suffering from certain diseases
Taking medicines for specific diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R56.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Febrile convulsions</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>First intervention group: The intervention method is a group of children aged 6 months to 60 months who have seizures caused by fever and have indications for drug therapy. Phenobarbital drug is given to this group in the amount of 3 to 5 mg per kilogram daily in two divided doses, and after 5 half-lives from the start of the drug (about 15 days), the serum level of the drug is measured by hplc method. And the number of convulsions and the intervals between convulsions and the side effects of the drug are checked before and after taking the drug.</i_keyword>
      <i_keyword>Intervention group: The intervention method is a group of children aged 6 months to 60 months who have seizures caused by fever and have indications for drug therapy. In this drug group, levetiracetam is given at a dosage of 10 to 20 mg per kg twice a day. and after 5 half-lives from the start of the drug (about 15 days), the serum level of the drug is measured by hplc method. And the number of convulsions and the intervals between convulsions and the side effects of the drug are checked before and after taking the drug.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of seizures after receiving levetiracetam. Timepoint: 14 days after starting the drug. Method of measurement: Questionnaire and questions from the patient's mother.</prim_outcome>
      <prim_outcome>The number of seizures after receiving phenobarbital. Timepoint: 14 days after starting the drug. Method of measurement: Questionnaire and questions from the patient's mother.</prim_outcome>
      <prim_outcome>Intervals between seizures after receiving levetiracetam. Timepoint: 14 days after starting the drug. Method of measurement: Questionnaire and questions from the patient's mother.</prim_outcome>
      <prim_outcome>Intervals between seizures after receiving phenobarbital. Timepoint: 14 days after starting the drug. Method of measurement: Questionnaire and questions from the patient's mother.</prim_outcome>
      <prim_outcome>Side effects after taking levetiracetam. Timepoint: 14 days after starting the drug. Method of measurement: Questionnaire and questions from the patient's mother.</prim_outcome>
      <prim_outcome>Side effects after taking phenobarbital. Timepoint: 14 days after starting the drug. Method of measurement: Questionnaire and questions from the patient's mother.</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>Sabzevar University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-01</approval_date>
        <contact_name>Ethics Committee of Sabzevar University of Medical Sciences</contact_name>
        <contact_address>Tohidshahr Blvd Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
