<?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>IRCT20240615062138N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-03-02</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effect of methylprednisolone pals in treatment of children with refractory epilepsy</public_title>
      <acronym></acronym>
      <scientific_title>The efficasy of treatment with 5 days methylprednisolone pals on electroencephalography in children with refractory epilepsy .</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77469</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Refractory epilepsy.</hc_freetext>
      <i_freetext>Intervention group:This intervention is conducted in patients based on the history and clinical examination of seizures and confirmed in the ideal state of the brain EEG. The method of working is that by diagnosing patients who refer to the Children's Neuroscience Clinic of Shohadaye  Tajrish and Mofid Hospitals (based on the include and exclude criteria of the study) and in the sleep or wake of EEG, they obtain a written consent. They are then hospitalized in the neurological section of the children.As soon as the routine tests are hospitalized, infectious examination and electrolytes and kidney function are taken from the patient and if they do not have infectious issues and other exclusion at a dose of 20 mg / kg body weight methylprednisolon for 5 consecutive days in a row with vital symptoms and symptoms. Registration is injected regularly during the medication. Evaluated during hospitalization and third day.  One day after receiving the last dose of the day, the EEG will be taken again in sleep or wake up. The patient will be discharged by age and gender after general recovery and seizures) in a number of anti -epithelials related to the type of seizures (and will be followed for 2 years in 6, 12,18 and 24 followed up. Clinical symptoms and seizures control, drug complications and EEG findings will be investigated..</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Khatereh Bagheramiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.28, Haftlang st., Southest Adl st., Punak,Tehran city</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1916994603</zip>
        <telephone>+98 911 210 6334</telephone>
        <email>Khatereh.bagheramiri@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khatereh Bagheramiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.28, Haftlang St, Southest Adl St, Punak,Tehran City</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1916994603</zip>
        <telephone>+98 911 210 6334</telephone>
        <email>Khatereh.bagheramiri@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children who based on history and physical examination and electroencephalogram  have epilepsy syndromes such as Infantile spasm, Landau-Kleffner syndrome, seizure disorders with waves like hypsarrythmia or burst suppression pattern</inclusion_criteria>
      <agemin>3 months</agemin>
      <agemax>14 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Fever
leukocytosis
high ESR and CRP
positivity of blood culture
positivity of covid PCR test
unknown metabolic disorders
positive PPD test,
age under 2 months or age over 15 years
cases where corticosteroid use is contraindicated</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G40.919</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Epilepsy, unspecified, intractable, without status epilepticus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:This intervention is conducted in patients based on the history and clinical examination of seizures and confirmed in the ideal state of the brain EEG. The method of working is that by diagnosing patients who refer to the Children's Neuroscience Clinic of Shohadaye  Tajrish and Mofid Hospitals (based on the include and exclude criteria of the study) and in the sleep or wake of EEG, they obtain a written consent. They are then hospitalized in the neurological section of the children.As soon as the routine tests are hospitalized, infectious examination and electrolytes and kidney function are taken from the patient and if they do not have infectious issues and other exclusion at a dose of 20 mg / kg body weight methylprednisolon for 5 consecutive days in a row with vital symptoms and symptoms. Registration is injected regularly during the medication. Evaluated during hospitalization and third day.  One day after receiving the last dose of the day, the EEG will be taken again in sleep or wake up. The patient will be discharged by age and gender after general recovery and seizures) in a number of anti -epithelials related to the type of seizures (and will be followed for 2 years in 6, 12,18 and 24 followed up. Clinical symptoms and seizures control, drug complications and EEG findings will be investigated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The changes and improvement of EEG before and after receiving methylprednisolone pulse. Timepoint: before the start of the intervention and one day after receiving the intervention and 6, 12, 18, 24 months after the intervention. Method of measurement: Questionnaire and reading and comparison of EEGs by a specialist in pediatric neurology and a specialist in pediatric neurology and electrophysiology and epilepsy fellowship.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-27</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti University of Medical Sciences and Healthcare Services،Arabi street, Yemen street, Tehran city. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
