<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02229123</url>
  </required_header>
  <id_info>
    <org_study_id>2014-000791-26</org_study_id>
    <nct_id>NCT02229123</nct_id>
  </id_info>
  <brief_title>Levetiracetam Treatment of Neonatal Seizures: Safety and Efficacy Phase II Study</brief_title>
  <acronym>LEVNEONAT-1</acronym>
  <official_title>Levetiracetam Efficacy and Safety as First-line Treatment of Neonatal Seizures Occuring in Hypoxic-ischemic Encephalopathy Context</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Tours</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Amiens University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Tours</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      LEVNEONAT is a multicentre French clinical trials with the aim to develop new treatment&#xD;
      strategies for the treatment of neonatal seizures using Levetiracetam. The purpose of this&#xD;
      study is to determine the correct dosing, safety and efficacy for intravenous levetiracetam&#xD;
      as first line treatment in term newborn babies with seizures in hypoxic-ischemic&#xD;
      encephalopathy context. This new anticonvulsivant drug is a promising treatment for seizures&#xD;
      in newborns.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Article Focus&#xD;
&#xD;
        -  The principal aim of LEVNEONAT-1 is to determine the levetiracetam optimal dose defined&#xD;
           as the highest efficient dose under toxicity restrictions for treating neonatal&#xD;
           seizures.&#xD;
&#xD;
        -  LEVNEONAT-1 is an open-label, sequential dose-finding study with 3 increasing dose&#xD;
           levels of levetiracetam.&#xD;
&#xD;
      Strenghts and limitation of study&#xD;
&#xD;
        -  For the first time, levetiracetam will be used as the first-line treatment of neonatal&#xD;
           seizures and not as an add-on therapy.&#xD;
&#xD;
        -  Statistical model is designed for a rare clinical situation with a sequential adaptive&#xD;
           method updating in real time the dose allocation for next patient by using all available&#xD;
           data from previous participants.&#xD;
&#xD;
        -  The targeted population, i.e. the newborn less than 3 days of life, is particularly&#xD;
           sensitive and the written consent of both parents is required before the levetiracetam&#xD;
           administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 27, 2018</start_date>
  <completion_date type="Anticipated">March 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 27, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>LEVNEONAT-1 is an open and sequential dose-finding study with 1 loading dose of 30, 40 and 50 mg/kg and 8 quarter-loading maintenance doses for a 3-day treatment. The optimal dose will be the one estimated to be associated with a toxicity not exceeding 10% and an efficacy higher than 60%. Efficacy has been defined by a seizure burden reduction of 80% after the loading dose. A 2-patient cohort will be necessary at each dose level to consider an upper dose level assignment with a dynamic consideration of each participant data. The maximal sample size expected is 30 participants patients.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Levetiracetam Efficacy on EEG recording</measure>
    <time_frame>the period just before the LEV loading dose (from 20 min to 3 hours) and the 3 hour time-interval from 1 hour 15 min (T11/4) to 4 hours 15 min (T41/4) after the starting of loading dose infusion (T0)</time_frame>
    <description>Efficacy has been defined as an 80% reduction of seizure burden on EEG recording.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levetiracetam Short-Term Toxicity</measure>
    <time_frame>6 days from the loading dose</time_frame>
    <description>Short-term toxicity focuses on 4 adverse events potentially attributable to LEV occurring in the 6 days following the loading dose: i) Severe apnoea leading to mechanical ventilation during the 4-hour period following the LEV infusion; ii) Anaphylactic shock occurring during the 30 minutes following the LEV infusion; iii) Toxic epidermic necrosis; iv) Stevens-Jonhson Syndrome. Short-term toxicity has been designed to trigger quickly a decreasing dose allocation to the next potential participant through a e-CRF alert.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levetiracetam Long-Term Toxicity</measure>
    <time_frame>30 days from the loading dose</time_frame>
    <description>Long-term toxicity includes all the adverse events observed and declared to the pharmacovigilance unit up to the hospital discharge or the 30th day of life at the latest.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Levetiracetam Elimination Clearance</measure>
    <time_frame>at 30 min, 4 hours and 7 hours after the end of loading dose infusion, respectively and at 1 to 3 hours and 12 hours to 18 hours after the last levetiracetam maintenance dose, respectively.</time_frame>
    <description>The mean values of the elimination clearance and their respective interindividual variability will be estimated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levetiracetam Distribution Volume</measure>
    <time_frame>at 30 min, 4 hours and 7 hours after the end of loading dose infusion, respectively and at 1 to 3 hours and 12 hours to 18 hours after the last levetiracetam maintenance dose, respectively.</time_frame>
    <description>The mean values of distribution volumes and their respective interindividual variability will be estimated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasmatic Levetiracetam Maximal Concentration</measure>
    <time_frame>30 min, 4 hours and 7 hours after the end of Levetiracetam loading dose infusion</time_frame>
    <description>Plasmatic Peak Value of Levetiracetam Loading dose will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levetiracetam Loading Dose Area under Curve</measure>
    <time_frame>30 min, 4 hours and 7 hours after the end of Levetiracetam loading dose infusion</time_frame>
    <description>ndividual PK parameters will be estimated and used to calculated the AUC corresponding to the loading dose, after the first maintenance dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levetiracetam Entire Treatment Area Under Curve</measure>
    <time_frame>at 30 min, 4 hours and 7 hours after the end of loading dose infusion, respectively and at 1 to 3 hours and 12 hours to 18 hours after the last Levetiracetam maintenance dose, respectively.</time_frame>
    <description>Individual PK parameters will be estimated and used to calculated the cumulative AUC of the entire treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seizure recurrence from the Efficacy criteria completion to day 6</measure>
    <time_frame>from 4h15 after the loading dose to 6 days</time_frame>
    <description>Clinical or electric seizures recurrence after the efficacy criteria assessment and up to the complete levetiracetam elimination (estimated 5 half-life) will be reported by investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levetiracetam Efficacy according to the seizure burden intensity prior to loading dose</measure>
    <time_frame>after the complete recruting period</time_frame>
    <description>A new analysis will be performed retrospectively by adjusting the efficacy criteria to the seizure burden on the pre-treatment EEG. Two subgroups will be considered according to the seizure burden (SB) intensity on the pre-treatment EEG, i.e equal or above to 50% of the EEG recording duration (high SB group) and strictly under 50% of it (low SB group), respectively. LEV efficacy will be considered positive when a SB reduction of 50% will be observed on the post-treatment EEG recording in the high SB group whereas the reduction of 80% will be still valid for the low SB group.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Neonatal Seizures</condition>
  <arm_group>
    <arm_group_label>Intravenous levetiracetam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 loading dose of 30, 40 or 50 mg/kg administered intra-venously. Maintenance treatment: one intra-venous injection /8h, 8 doses in total for a 3-day treatment. Maintenance dose corresponds to the loading dose quarter i.e. 7.5, 10 or 12.5 mg/kg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous Levetiracetam</intervention_name>
    <description>Open-study. If seizure lasting more than 3 minutes on EEG recording or brief repeated seizures (more or equal to 2 seizures lasting more than 20 seconds on a 1 hour-interval), the loading-dose of LEV allocated to patient is infused followed by the 8 maintenance dose.</description>
    <arm_group_label>Intravenous levetiracetam</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Eligibility Criteria:&#xD;
&#xD;
          1. Male or female term baby with gestational age of 36-43 weeks and postnatal age &lt; or=&#xD;
             72 hours&#xD;
&#xD;
          2. One or more of the following :&#xD;
&#xD;
               -  APGAR score &lt; 5 at 5 mins&#xD;
&#xD;
               -  Umbilical cord or arterial blood sample (within one hour after birth): pH &lt;7.0 or&#xD;
                  base deficit &gt; or = 16 mmol/L or lactates &gt; or equal to 11 mmol/L&#xD;
&#xD;
               -  Abnormal neurological examination before 6 hours of life&#xD;
&#xD;
          3. Suspected clinical or EEG seizures&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  A seizure lasting more than 3 minutes or more than 2 seizures lasting more than 20&#xD;
             seconds on a 1 hour-period on standard EEG recording 4 hours before the levetiracetam&#xD;
             loading dose&#xD;
&#xD;
          -  Availability of 8 electrode EEG recording&#xD;
&#xD;
          -  Written informed consent of both parents or the authorized guardians&#xD;
&#xD;
          -  Subscription to social security health insurance are required&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspected or confirmed brain malformation, inborn error of metabolism, genetic&#xD;
             syndrome or major congenital malformation&#xD;
&#xD;
          -  Congenital (in utero) infection (TORCH)&#xD;
&#xD;
          -  Babies who have received phenobarbital or any other anticonvulsive medication other&#xD;
             than a bolus of midazolam for intubation&#xD;
&#xD;
          -  Anuria/renal failure defined as serum creatinine &gt; 150 micromol/L&#xD;
&#xD;
          -  Seizures secondary to treatable metabolic etiology as hypoglycemia and hypocalcemia&#xD;
&#xD;
          -  Corrected QT interval (QTc) greater than 450 milliseconds on the electrocardiogram&#xD;
             (ECG) prior to inclusion in the presence or absence of a condition that promotes QT&#xD;
             prolongation (hypokalemia, maternal treatment during childbirth or treatment of the&#xD;
             child with drugs known to prolong QT),&#xD;
&#xD;
          -  Participation to an interventional research study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>36 Weeks</minimum_age>
    <maximum_age>43 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Geraldine Favrais, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital of Tours</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Geraldine FAVRAIS, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University hospital of Tours</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Geraldine Favrais, Dr</last_name>
    <phone>0247474749</phone>
    <email>g.favrais@chu-tours.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Estelle Boivin</last_name>
    <phone>0247474620</phone>
    <email>e.boivin@chu-tours.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Service de réanimation néonatale</name>
      <address>
        <city>Angers</city>
        <zip>49000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephane Le Bouedec, Dr</last_name>
      <email>StLeBouedec@chu-angers.fr</email>
    </contact>
    <contact_backup>
      <last_name>Geraldine Gascoin, Pr</last_name>
      <email>GeGascoin@chu-angers.fr</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Service de réanimation néonatale</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Florence Flamein, Dr</last_name>
      <email>Florence.flamein@chru-lille.fr</email>
    </contact>
    <contact_backup>
      <last_name>Laurent Storme, Pr</last_name>
      <email>laurent.storme@chru-lille.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Florence Flamein, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Service de réanimation et service néonatale</name>
      <address>
        <city>Orleans</city>
        <zip>45100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Bérengère KIRECHE, PH</last_name>
      <email>berengere.kireche@chr-orleans.fr</email>
    </contact>
    <contact_backup>
      <last_name>Evelyne WERNER, PH</last_name>
      <email>evelyne.werner@chr-orleans.fr</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Service de réanimation néonatale et pédiatrique</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Isabelle GUELLEC, PH</last_name>
      <email>isabelle.guellec@aphp.fr</email>
    </contact>
    <contact_backup>
      <last_name>Pierre_Louis LEGER, PH</last_name>
      <email>pierre-louis.leger@aphp.fr</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Service de réanimation néonatale</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Nathalie BEDNAREK, PU-PH</last_name>
      <email>nbednarek@chu-reims.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Néonatologie</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick Pladys, Pr</last_name>
      <email>patrick.pladys@chu-rennes.fr</email>
    </contact>
    <contact_backup>
      <last_name>Alain Beuchee, Pr</last_name>
      <email>alain.beuchee@chu-rennes.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Patrick Pladys, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Service de Pédiatrie néonatale et réanimation</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexandra Chadie, Dr</last_name>
      <email>alexandra.chadie@chu-rouen.fr</email>
    </contact>
    <contact_backup>
      <last_name>Stephane Marret, Pr</last_name>
      <email>stephane.marret@chu-rouen.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Alexandra Chadie, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Service de Néonatologie</name>
      <address>
        <city>Tours</city>
        <zip>37 000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Geraldine Favrais, Dr</last_name>
      <phone>0247474749</phone>
      <email>g.favrais@chu-tours.fr</email>
    </contact>
    <contact_backup>
      <last_name>Estelle Boivin</last_name>
      <phone>0247474620</phone>
      <email>e.boivin@chu-tours.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Geraldine Favrais, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>seizures</keyword>
  <keyword>neonates</keyword>
  <keyword>anticonvulsant treatment</keyword>
  <keyword>levetiracetam</keyword>
  <keyword>hypoxic-ischemic encephalopathy</keyword>
  <keyword>electroencephalography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Seizures</mesh_term>
    <mesh_term>Hypoxia-Ischemia, Brain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Levetiracetam</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02229123
org study id: 2014-000791-26
nct id: NCT02229123
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
LEVNEONAT is a multicentre French clinical trials with the aim to develop new treatment
      strategies for the treatment of neonatal seizures using Levetiracetam. The purpose of this
      study is to determine the correct dosing, safety and efficacy for intravenous levetiracetam
      as first line treatment in term newborn babies with seizures in hypoxic-ischemic
      encephalopathy context. This new anticonvulsivant drug is a promising treatment for seizures
      in newborns.
Article Focus

        -  The principal aim of LEVNEONAT-1 is to determine the levetiracetam optimal dose defined
           as the highest efficient dose under toxicity restrictions for treating neonatal
           seizures.

        -  LEVNEONAT-1 is an open-label, sequential dose-finding study with 3 increasing dose
           levels of levetiracetam.

      Strenghts and limitation of study

        -  For the first time, levetiracetam will be used as the first-line treatment of neonatal
           seizures and not as an add-on therapy.

        -  Statistical model is designed for a rare clinical situation with a sequential adaptive
           method updating in real time the dose allocation for next patient by using all available
           data from previous participants.

        -  The targeted population, i.e. the newborn less than 3 days of life, is particularly
           sensitive and the written consent of both parents is required before the levetiracetam
           administration.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: LEVNEONAT-1 is an open and sequential dose-finding study with 1 loading dose of 30, 40 and 50 mg/kg and 8 quarter-loading maintenance doses for a 3-day treatment. The optimal dose will be the one estimated to be associated with a toxicity not exceeding 10% and an efficacy higher than 60%. Efficacy has been defined by a seizure burden reduction of 80% after the loading dose. A 2-patient cohort will be necessary at each dose level to consider an upper dose level assignment with a dynamic consideration of each participant data. The maximal sample size expected is 30 participants patients.
primary purpose: Treatment
masking: None (Open Label)
measure: Levetiracetam Efficacy on EEG recording
time frame: the period just before the LEV loading dose (from 20 min to 3 hours) and the 3 hour time-interval from 1 hour 15 min (T11/4) to 4 hours 15 min (T41/4) after the starting of loading dose infusion (T0)
description: Efficacy has been defined as an 80% reduction of seizure burden on EEG recording.
measure: Levetiracetam Short-Term Toxicity
time frame: 6 days from the loading dose
description: Short-term toxicity focuses on 4 adverse events potentially attributable to LEV occurring in the 6 days following the loading dose: i) Severe apnoea leading to mechanical ventilation during the 4-hour period following the LEV infusion; ii) Anaphylactic shock occurring during the 30 minutes following the LEV infusion; iii) Toxic epidermic necrosis; iv) Stevens-Jonhson Syndrome. Short-term toxicity has been designed to trigger quickly a decreasing dose allocation to the next potential participant through a e-CRF alert.
measure: Levetiracetam Long-Term Toxicity
time frame: 30 days from the loading dose
description: Long-term toxicity includes all the adverse events observed and declared to the pharmacovigilance unit up to the hospital discharge or the 30th day of life at the latest.
measure: Levetiracetam Elimination Clearance
time frame: at 30 min, 4 hours and 7 hours after the end of loading dose infusion, respectively and at 1 to 3 hours and 12 hours to 18 hours after the last levetiracetam maintenance dose, respectively.
description: The mean values of the elimination clearance and their respective interindividual variability will be estimated.
measure: Levetiracetam Distribution Volume
time frame: at 30 min, 4 hours and 7 hours after the end of loading dose infusion, respectively and at 1 to 3 hours and 12 hours to 18 hours after the last levetiracetam maintenance dose, respectively.
description: The mean values of distribution volumes and their respective interindividual variability will be estimated.
measure: Plasmatic Levetiracetam Maximal Concentration
time frame: 30 min, 4 hours and 7 hours after the end of Levetiracetam loading dose infusion
description: Plasmatic Peak Value of Levetiracetam Loading dose will be assessed.
measure: Levetiracetam Loading Dose Area under Curve
time frame: 30 min, 4 hours and 7 hours after the end of Levetiracetam loading dose infusion
description: ndividual PK parameters will be estimated and used to calculated the AUC corresponding to the loading dose, after the first maintenance dose.
measure: Levetiracetam Entire Treatment Area Under Curve
time frame: at 30 min, 4 hours and 7 hours after the end of loading dose infusion, respectively and at 1 to 3 hours and 12 hours to 18 hours after the last Levetiracetam maintenance dose, respectively.
description: Individual PK parameters will be estimated and used to calculated the cumulative AUC of the entire treatment.
measure: Seizure recurrence from the Efficacy criteria completion to day 6
time frame: from 4h15 after the loading dose to 6 days
description: Clinical or electric seizures recurrence after the efficacy criteria assessment and up to the complete levetiracetam elimination (estimated 5 half-life) will be reported by investigator.
measure: Levetiracetam Efficacy according to the seizure burden intensity prior to loading dose
time frame: after the complete recruting period
description: A new analysis will be performed retrospectively by adjusting the efficacy criteria to the seizure burden on the pre-treatment EEG. Two subgroups will be considered according to the seizure burden (SB) intensity on the pre-treatment EEG, i.e equal or above to 50% of the EEG recording duration (high SB group) and strictly under 50% of it (low SB group), respectively. LEV efficacy will be considered positive when a SB reduction of 50% will be observed on the post-treatment EEG recording in the high SB group whereas the reduction of 80% will be still valid for the low SB group.
arm group label: Intravenous levetiracetam
arm group type: Experimental
description: 1 loading dose of 30, 40 or 50 mg/kg administered intra-venously. Maintenance treatment: one intra-venous injection /8h, 8 doses in total for a 3-day treatment. Maintenance dose corresponds to the loading dose quarter i.e. 7.5, 10 or 12.5 mg/kg.
intervention type: Drug
intervention name: Intravenous Levetiracetam
description: Open-study. If seizure lasting more than 3 minutes on EEG recording or brief repeated seizures (more or equal to 2 seizures lasting more than 20 seconds on a 1 hour-interval), the loading-dose of LEV allocated to patient is infused followed by the 8 maintenance dose.
arm group label: Intravenous levetiracetam
criteria: 
gender: All
minimum age: 36 Weeks
maximum age: 43 Weeks
healthy volunteers: No
last name: Geraldine Favrais, Dr
role: Study Chair
affiliation: University Hospital of Tours
last name: Geraldine FAVRAIS, Dr
role: Principal Investigator
affiliation: University hospital of Tours
last name: Geraldine Favrais, Dr
phone: 0247474749
email: g.favrais@chu-tours.fr
last name: Estelle Boivin
phone: 0247474620
email: e.boivin@chu-tours.fr
facility: 
status: Recruiting
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status: Not yet recruiting
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country: France
responsible party type: Sponsor
mesh term: Seizures
mesh term: Hypoxia-Ischemia, Brain
mesh term: Levetiracetam