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IRCT20200131046317N3 IRCT 2021-08-25 Mashhad University of Medical Sciences Comparison of the effects of phenobarbital and levetiracetam on neonatal seizure after discharge Comparison of the outcomes of neonatal seizure treatment with phenobarbital versus levetiracetam after discharge 2021-09-01 anticipated 60 Complete https://irct.ir/trial/52717 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The envelopes will be prepared by one of the members of the research team and the random numbers generated by the ''www.randomization.com'' website will be printed and placed in each envelope. The envelopes are sealed and their contents are not visible from outside. At first, purpose of the study is explained for each participants and after filling out the consent form, each participant selects an envelope and opens it and based on its content, the participant will be placed in either control or intervention group, Blinding description: In this study, participants are not aware of the type of treatment and the intervention. Also, outcome assessors are unaware of the grouping. 3 convulsion of newborn. Intervention 1: Intervention group: Patients in this group are treated with 30 mg/kg levetiracetam daily after discharge and are followed for recurrence of seizures, complications and neonatal development 3 and 6 months after discharge. The duration of treatment will be decided based on examinations and EEG. Intervention 2: Control group: Patients in this group are treated with 5 mg/kg phenobarbital daily after discharge and are followed for recurrence of seizures, complications and neonatal development 3 and 6 months after discharge. The duration of treatment will be decided based on examinations and EEG. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible through an email to the corresponding author. To whom: Data will be available for researchers in universities and other scientific institutes. Conditions: Data can be accessible 6 months after results are published. Where to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. How to obtain: Carrying out analysis on data is permitted. Comments:
public Nazanin Saeidi Zand
Ghaem Hospital, Ahmad Abad Avenue
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2496 dr.nazanin_zand@yahoo.com Mashhad University of Medical Sciences scientific Dr.Javad Akhondian
Ghaem hospital, Ahmad Abad Ave.
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2496 akhondianj@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) The age when seizures started is less than one month History of at least one seizure with an unknown cause Need for treatment at the time of discharge based on history, type of seizure and EEG 1 day 1 month Both Finding any errors of metabolism as the cause of seizures Gestational age is below 36 weeks Congenital metabolic disorders Finding any structural abnormalities in the brain on magnetic resonance imaging of the brain or head ultrasound P90 Convulsions of newborn Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group are treated with 30 mg/kg levetiracetam daily after discharge and are followed for recurrence of seizures, complications and neonatal development 3 and 6 months after discharge. The duration of treatment will be decided based on examinations and EEG. Control group: Patients in this group are treated with 5 mg/kg phenobarbital daily after discharge and are followed for recurrence of seizures, complications and neonatal development 3 and 6 months after discharge. The duration of treatment will be decided based on examinations and EEG. Reoccurrence of seizures. Timepoint: 3 and 6 months after discharge. Method of measurement: Based on parents' reports. The newborn's growth. Timepoint: 3 and 6 months after discharge. Method of measurement: Clinical observation. Mashhad University of Medical Sciences Approved 2021-01-19 Ethics Committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)