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IRCT20220619055221N1 IRCT 2022-11-09 Urmia University of Medical Sciences Research Vice President Comparing the effects of levetiracetam and phenytoin in the treatment of neonatal seizures efficacy of Levetiracetam compared to intravenous Phenytoin in treatment of acute phase of neonatal seizure 2022-11-22 anticipated 60 Complete https://irct.ir/trial/64286 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: in this study, the block randomization method will be used, so that at first all the possible states of the combination AAABBB will be listed, then according to the sample size (60) and the block size equal to 6, 10 blocks will be randomly selected. will be selected. The selection of randomization will be such that first all possible combinations of 6 will be listed and a code will be assigned for each, and then 10 blocks will be selected and listed in order, and the allocation of people will be based on this list. The codes will be secret and only available to the epidemiological consultant. All steps will be done under the supervision of an epidemiologist and using Random Allocation software, version one, Blinding description: Due to the nature of the intervention, the participants, the researcher and the outcome evaluator do not know the type of intervention and it will only be based on the codes that will be available to an independent person as an observer to take action in case of possible complications and problems. 3 Neonatal seizure. Intervention 1: Intervention group: Levetiracetam Dose 20 mg/kg starting and continuing to 10 mg/kg. Intervention 2: Intervention group: Phenytoin Dose 20 mg/kg starting and continuing to 3-5 mg/kg. Yes - There is a plan to make this available What will be shared: Information about the infant and the horse's anticonvulsant treatment can be shared. When: It is possible to start the access period 6 months after the publication of the study results. To whom: Researchers in the institutions of universities of medical sciences can apply for them. Conditions: After sending the email, it will be possible to access the data. Where to obtain: Dr. Aireza Abdi alireza.abdi129@gmail.com How to obtain: 6 months after printing the results, send an email confirming the request so that the requested data can be sent. Comments:
public Parvaneh Babaey Sisi
No.2 ,shahrdari st, Sis
Shabestar Iran (Islamic Republic of) 5385136998 +98 41 4247 6768 parvanehbabaey@gmail.com Oroumia University of Medical Sciences scientific Alireza abdi
Kashani st
Urmia Iran (Islamic Republic of) 5761715335 +98 44 3224 1967 alireza.abdi129@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) neonate with seizure term neonate up to 28 days preterm neonate up to 44 weeks of gestational age 1 day 28 days Both neonate without seizure P90 Convulsions of newborn Treatment - Drugs Treatment - Drugs Intervention group: Levetiracetam Dose 20 mg/kg starting and continuing to 10 mg/kg Intervention group: Phenytoin Dose 20 mg/kg starting and continuing to 3-5 mg/kg Efficacy of phenytoin and levetiracetam in the treatment of neonatal seizures. Timepoint: The first 24 hours after the drug. Method of measurement: No recurrence of seizures in the first 24 hours after the drug. Urmia University of Medical Sciences Research Vice President Approved 2022-10-22 Ethics Committee of Urmia University of Medical Sciences Urmia University of Medical Sciences, Urmia University of Medical Sciences, Resalat St Urmia West Azarbaijan Iran (Islamic Republic of)