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IRCT20090412001808N7 IRCT 2020-01-24 Mazandaran University of Medical Sciences The effect of Levetiracetam and phenobarbital in treatment of neonatal seizures Clinical trial of comparison of intravenous Levetiracetam and phenobarbital for first line treatment of acute neonatal seizures 2018-05-22 anticipated 50 Complete https://irct.ir/trial/43848 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to two groups of intervention and control using block randomization with block sizes of 4. Randomization will be done using the software randomization option in Excel. The randomization process is performed by the study methodology consultant and clinical researchers are not aware of the randomization process. 3 Acute neonatal seizure. Intervention 1: Intervention group: Levetiracetam made by Estragen Company, Switzerland with initial loading dose of 30 mg/kg with slow intravenous infusion is injected for 15 minutes and maintenance dose of 10 mg/kg for 12 hours diluted with normal saline. If the seizure is controlled, the injectable drug will gradually decrease and become orally administered at a maintenance dose of 5 mg/kg/day. Intervention 2: Control group: Phenobarbital drug produced by Pars Darou Company is injected at a loading dose of 20 mg/kg which can be increased up to 40 mg/kg if seizure is not controlled. If the seizure is stopped, the injectable drug will gradually decrease and become orally administered at a maintenance dose of 5 mg/kg/day. Yes - There is a plan to make this available What will be shared: Part of the data is shareable after people are unrecognizable When: Starting from April 2020 To whom: People working in academic institutions Conditions: The data will be used for research and surveillance purposes, with the confidentiality of individuals' personal information Where to obtain: Send email to Dr. Ali Abbaskhanian, snali45@yahoo.com How to obtain: Written Request from Research Deputy of Mazandaran University of Medical Sciences and Dr. Abbaskhanian Comments:
public Dr. Ali Abbaskhanian
Bouali hospital, Pasdaran Blv, Sari, Iran
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 2334 snali45@yahoo.com Mazandaran University of Medical Sciences scientific Dr. Ali Abbaskhanian
Buali Hospital, Pasdaran Boulevard, Sari, Iran
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 2334 snali45@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Term neonates Age ≤ 28 days Clinical seizures requiring treatment based on the diagnosis of a neonatalologist Seizure diagnosis based on pediatric neurologist diagnosis and EEG interpretation Written informed consent of parents 1 day 28 days Both Renal failure Seizures caused by electrolyte disorders such as hypocalcemia and hypoglycemia Patients whose seizures respond to vitamin B6 administration Sensitivity to Levetiracetam or phenobarbital Structure Anomaly Asphyxia G40 Epilepsy and recurrent seizures Treatment - Drugs Treatment - Drugs Intervention group: Levetiracetam made by Estragen Company, Switzerland with initial loading dose of 30 mg/kg with slow intravenous infusion is injected for 15 minutes and maintenance dose of 10 mg/kg for 12 hours diluted with normal saline. If the seizure is controlled, the injectable drug will gradually decrease and become orally administered at a maintenance dose of 5 mg/kg/day. Control group: Phenobarbital drug produced by Pars Darou Company is injected at a loading dose of 20 mg/kg which can be increased up to 40 mg/kg if seizure is not controlled. If the seizure is stopped, the injectable drug will gradually decrease and become orally administered at a maintenance dose of 5 mg/kg/day. Seizure. Timepoint: 30 min, 24 hour up to 1 week, 1st month, 2nd month, 3rd month. Method of measurement: Clinical examination and observation of paroxysmal movements of the neonate. Sizure recurrence. Timepoint: 30 min, 24 hour up to 1 week, 1st month, 2nd month, 3rd montt. Method of measurement: Clinical examination and observation. Mazandaran University of Medical Sciences Approved 2019-06-11 Ethics committee of Mazandaran University of Medical Sciences Vice chancellor for research, Mazandaran University of Medical Sciences, Moallem Square, Sari, Iran Sari Mazandaran Iran (Islamic Republic of)