<?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>IRCT20090813002342N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-31</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Once or twice daily dose of phenobarbital  to control seizure in neonates</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of intravenous phenobarbital as once or twice daily dose in neonates with seizure in NICU</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36120</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: By simple randomization method, patients who met the inclusion criteria and completed informed consent were assigned to two groups. Random number generation software (using www.random.org) determined a number for each patient, if the number was odd, the patient was assigned to group 1 and if it was even, the patient was assigned to group 2. The randomization process was performed by the ward supervisor (who was independent of the principal investigators). Randomization was performed when the patient entered the study and the intervention was assigned according to his group therapy, Blinding description: If phenobarbital was prescribed for a baby due to seizures, it was written by the treating physician and the trained head nurse placed the baby in group 1 or 2 according to a random code obtained from www.random.org (odd or even). Due to the different ways of using phenobarbital, we were able to blind only the outcome assessor and data analyst to the study groups. All patients received intravenous phenobarbital with an initial dose of 20 mg / kg and, if necessary, increased by 10 mg / kg every 5 minutes to a maximum of 40 mg / kg. Then, group 1 patients received a single maintenance dose of 5 mg / kg. The daily dose and group 2 patients also received 5.2 mg / kg every 12 hours.</study_design>
      <phase>3</phase>
      <hc_freetext>Convulsions of newborn.</hc_freetext>
      <i_freetext>Intervention 1: Group 1 (once daily): Patients were received intravenous (IV) phenobarbital with an initial dose of 20 mg/kg and as needed with an increase of 10 mg/kg every 15 minutes to a maximum of 40 mg/kg and a maintenance dose of 5 mg/kg/day for 5 days. All of phenobarbital ampules (200 mg/ml) were prepared from Darou Pakhsh Co. Iran. Drug was administered at a maximum rate of 1 mg/kg/min as intravenous infusion. Intervention 2: Group 2 (twice daily): Patients were received IV phenobarbital with an initial dose of 20 mg/kg and, if necessary, an increase of 10 mg/kg every 15 minutes up to a maximum of 40 mg/kg, followed by a dose of 2.5 mg/kg every 12 hours for 5 days. The first maintenance dose was used 12 hours after the loading dose. All of phenobarbital ampules (200 mg/ml) were prepared from Darou Pakhsh Co. Iran. Drug was administered at a maximum rate of 1 mg/kg/min intravenous infusion.</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 not enough permission to disseminate patient information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammadreza Rafati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar Square, Sari, Mazandaran Province</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4847116548</zip>
        <telephone>+98 11 3354 3081</telephone>
        <email>mrrafati@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadreza Rafati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu-Ali Sina Hospital, Sari, Mazandaran Province</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815838477</zip>
        <telephone>+98 11 3334 3014</telephone>
        <email>vghaffari@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Newborns with seizures that use IV phenobarbital</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>28 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Neonates with liver or kidney failure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Convulsions of newborn</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>Group 1 (once daily): Patients were received intravenous (IV) phenobarbital with an initial dose of 20 mg/kg and as needed with an increase of 10 mg/kg every 15 minutes to a maximum of 40 mg/kg and a maintenance dose of 5 mg/kg/day for 5 days. All of phenobarbital ampules (200 mg/ml) were prepared from Darou Pakhsh Co. Iran. Drug was administered at a maximum rate of 1 mg/kg/min as intravenous infusion.</i_keyword>
      <i_keyword>Group 2 (twice daily): Patients were received IV phenobarbital with an initial dose of 20 mg/kg and, if necessary, an increase of 10 mg/kg every 15 minutes up to a maximum of 40 mg/kg, followed by a dose of 2.5 mg/kg every 12 hours for 5 days. The first maintenance dose was used 12 hours after the loading dose. All of phenobarbital ampules (200 mg/ml) were prepared from Darou Pakhsh Co. Iran. Drug was administered at a maximum rate of 1 mg/kg/min intravenous infusion.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Phenobarbital plasma concentration. Timepoint: Before starting the phenobarbital maintenance dose and at third day of maintenance therapy. Method of measurement: by High Performance Liquid Chromatography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The numbers of new seizurs. Timepoint: During the study time for 5 days. Method of measurement: The visual report of responsible doctor or nurse.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-24</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Science</contact_name>
        <contact_address>Payambar Azam Complex, 18 Km Farah Abad Blvd., Sari, Mazandaran Province Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
