[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614815":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":34,"centralContacts":42,"locations":52,"responsibleParty":71,"collaborators":29,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":29,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":97,"whyStopped":29,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Mansoura University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Phenobarbital Arm ( Group A )","ACTIVE_COMPARATOR","Patients in Group A will receive PHENobarbital at a loading dose of 20 mg\u002Fkg within a 20-minute time frame from the start of treatment. If the seizure dose is not stopped after 20 minutes, another 20 mg\u002Fkg of the same medication will be added, and if the seizure dose is not stopped within the total time frame of 40 minutes, this will be considered a treatment failure. If seizures are controlled, patients will receive a maintenance dose of PHENobarbital 3-5 mg\u002Fkg\u002Fday IV\u002FPO, in 1-2 divided doses, starting 12 hours after the loading dose.",[13],"Drug: Phenobarbital",{"label":15,"type":10,"description":16,"interventionNames":17},"Levetiracetam Standard Dose Arm ( Group B )","Patients in Group B will receive levETIRAcetam at a loading dose of 30 mg\u002Fkg within a timeframe of 20 minutes from the start of seizures if the seizures don't stop. The same beginning dose will be repeated, in case the seizures don't stop within the 40-minute time frame, which leads to the treatment being considered a failure and a need to move to the second line of treatment. If seizures are controlled, patients will receive maintenance dose of levETIRAcetam 30 mg\u002Fkg\u002Fday IV or orally, divided into three daily doses.",[18],"Drug: Levetiracetam",{"label":20,"type":10,"description":21,"interventionNames":22},"Levetiracetam High Dose Arm ( Group C )","Patients in Group C will receive levETIRAcetam at a loading dose of 60 mg\u002Fkg within a timeframe of 20 minutes from the start of seizures if the seizures don't stop. The same beginning dose will be repeated, in case the seizures don't stop within the 40-minute time frame, which leads to the treatment being considered a failure and a need to move to the second line of treatment. If seizures are controlled, patients will receive maintenance dose of levETIRAcetam 60 mg\u002Fkg\u002Fday IV or orally, divided into three daily doses.",[18],[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Phenobarbital","Phenobarbital is strongly recommended by the World Health Organization as the first-line treatment of neonatal seizures and is the standard of care at most institutions",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Levetiracetam","levetiracetam has emerged as an alternative Anti-seizure medication that may offer improved safety and tolerability profiles.",[20,15],[35,39],{"name":36,"affiliation":37,"role":38},"Moetaza Soliman, Associate Professor","Faculty of Pharmacy, Mansoura University","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":41,"role":38},"Nada Abdelfattah, Associate Professor","University Children's Hospital, Mansoura University",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":29,"email":47},"Abdulwahab Alqarni","CONTACT","+966533655255","ph.abdulwahab@gmail.com",{"name":49,"role":45,"phone":50,"phoneExt":29,"email":51},"Mustafa Sharaf EL-Deen, Lecturer of Clinical Pharmacy","+201140102401","sharaf_eldeen@mans.edu.eg",[53,63],{"facility":41,"status":29,"city":54,"state":29,"zip":29,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":29},"Al Mansurah","Egypt","EG",{"type":58,"coordinates":59},"Point",[60,61],31.38069,31.03637,{"lat":61,"lon":60},{"facility":64,"status":29,"city":65,"state":29,"zip":29,"country":55,"countryCode":56,"cosmosGeoPoint":66,"geoPoint":70,"contacts":29},"Al Galaa Teaching Hospital","Cairo",{"type":58,"coordinates":67},[68,69],31.24967,30.06263,{"lat":69,"lon":68},{"type":38,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Abdulwahab Uosef Alqarni, M.Sc","Mansoura University, PhD student","100614815","phase-4-treatment-of-seizures-in-neonate-with-hie-100614815",false,"NCT07284498","Treatment of Seizures in Neonate With HIE","Treatment of Seizures in Neonate With Hypoxic Ischemic Encephalopathy","HIE","Inclusion Criteria:\n\n1. Neonates diagnosed with moderate or severe HIE.\n2. Presence of clinical seizures (focal \u002F generalized tonic \u002Fcolonic, myoclonic, subtle and spasms) and\u002For documented amplitude electroencephalogram (aEEG) abnormality within the first 72 hours.\n\nExclusion Criteria:\n\n1. Exclusive metabolic causes.\n2. Serum creatinine greater than 1.6 mg\u002Fdl.\n3. Known pyridoxine-dependent seizures.\n4. Prior treatment with anti-epileptic drugs.","ALL","1 Day","30 Days",{"count":86,"type":87},66,"ESTIMATED","INTERVENTIONAL",[90],"PHASE4","Aim of the study To evaluate and compare phenobarbital's and levetiracetam's safety and efficacy for treating seizures in neonates with moderate to severe HIE",[93,94],"Neonatal Seizures","HIE - Hypoxic - Ischemic Encephalopathy",[96,80,26,31],"Neonatal Seizure","NOT_YET_RECRUITING","2025-12-02",{"date":100,"type":101},"2025-12-16","ACTUAL",{"date":103,"type":87},"2026-01-01",{"date":105,"type":87},"2026-10",{"name":5,"class":6},2]