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IRCT20190526043717N1 IRCT 2019-05-31 Ghoum University of Medical Sciences Comparison of intravenous levetiracetam and phenobarbital in neonatal seizures Comparison of intravenous levetiracetam and phenobarbital for management of neonatal seizures 2019-06-10 anticipated 100 Complete https://irct.ir/trial/39842 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After obtaining informed consent, the random blocking method with a size of 4 will be allocated to each of the two treatment groups. Blocks will be determined randomly and using the PROC PLAN method in SAS 9.3 software by a biostatistician for the person who enters the study into the study, Blinding description: legal guardianship, as well as the investigator who measures the events related to intervention, will not be aware of the type of treatments, the coding method will be used to provide intervention, the code breaks will be available to the researcher after measuring the consequences as well as analysis of the results. 3 Neonatal Seizures. Intervention 1: Intervention group: Levetiracetam intravenous 20-40 mg/kg/day, 15mg/kg/day per 12 h. Intervention 2: Control group: Phenobarbital 20mg/kg two time a day, increasing dose up to 30mg/kg during 3 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no additional information
public Alireza Sadati
Khorami Hospital, Emam Street
Qom Iran (Islamic Republic of) 3713649373 +98 25 3665 1801 a-saadatimd@yahoo.com Ghoum University of Medical Sciences scientific Alireza Sadati
Khorami Hospital, Emam Street
Qom Iran (Islamic Republic of) 3713649373 +98 25 3665 1801 a-saadatimd@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) require for neonatal seizures management Weight > 2500gr birth age>37 weaks Individuals without renal dysfunction Individuals without dysfunction of the immune system 1 day 12 months Both Healthy individuals Weight <2500 gr Birth age <37 weaks renal dysfunction immune system dysfunction G40 Epilepsy and recurrent seizures Treatment - Drugs Placebo Intervention group: Levetiracetam intravenous 20-40 mg/kg/day, 15mg/kg/day per 12 h Control group: Phenobarbital 20mg/kg two time a day, increasing dose up to 30mg/kg during 3 days Seizures. Timepoint: 30 min, 24 h up to 1 w, 1th m, 2th m, 3th m. Method of measurement: clinical observation. Neonatal seizures recurrence. Timepoint: 24 h up to 1 weak, first month, two month, and three month after intervention. Method of measurement: clinical observation. Ghoum University of Medical Sciences Approved 2019-03-05 IR-MUQ-REC saheli qom Ghoum Iran (Islamic Republic of)