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IRCT20160523028008N23 IRCT 2022-06-13 Hamedan University of Medical Sciences The effect of levetiracetam and phenobarbital on the control of neonatal seizures Comparison of efficacy and safety of Levetiracetam and Phenobarbital in controlling neonatal seizures 2022-05-05 anticipated 40 Complete https://irct.ir/trial/63092 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into two groups based on a table of random numbers. A random number table is a set of numbers that are produced without a specific pattern or order and in a completely random manner and become a table. In order to use a random number table, the researcher must first predetermine the table to read the numbers for example, up, down, left, or right. Individuals receive a number based on the order of enrollment. Individual numbers are assigned to patients in the intervention group and even numbers are assigned to patients in the control group. assumption, Blinding description: According to randomization, the patient is assigned to one of the control or intervention groups. Drugs that have the same shape are prepared in the ward, drawn in a syringe, and then administered at the patient's bedside. Thus, the form of drug administration will be the same in both groups; based on it, the type of drug can not be determined. Parents of infants and the person who fills out the questionnaires will not know about the prescribed medicine and the form will be filled in according to the assigned code. 2-3 Convulsions of newborn. Intervention 1: Intervention group: Patients are treated with levetiracetam injection (500 mg / 5ml by Estragen Company, Switzerland) at a loading dose of 50 mg/kg and infusion rate of 2 mg/kg/min (within 10 Cc of normal saline) under cardiorespiratory monitoring. If seizures continue with the first dose of levetiracetam, the drug is re-loaded at a dose of 50 mg/kg by the same infusion rate (within 10 cc of normal saline). If the seizure does not stop or returns after 15 minutes, even after the second dose of medication, the treatment groups are changed. If the seizure does not stop or returns after 15 minutes after changing treatment groups, other anticonvulsant drugs are used. Intervention 2: Control group: Patients in the control group are treated with Phenobarbital injection (200mg/ml from Chemidarou company) at a loading dose of 20 mg/kg and at an infusion rate of 1 m/kg/min (within 10 Cc of normal saline) under cardiorespiratory monitoring,If the seizure continues with the first dose, phenobarbital is re-loaded by infusion at a dose of 20 mg per kg at the same rate as before. If the seizure does not stop or returns after 15 minutes, even after the second dose of medication, the treatment groups are changed. If the seizure does not stop or returns after 15 minutes after changing treatment groups, other anticonvulsant drugs are used. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information"
public Nader Faraji
Fatemi Blvd.
Hamadan Iran (Islamic Republic of) 6514845411 +98 912 248 3658 naderfaraji59@gmail.com Hamedan University of Medical Sciences scientific Nader Faraji
Fatemi Blvd.
Hamadan Iran (Islamic Republic of) 6517838695 +98 917 332 4977 naderfaraji59@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Gestational age of 36 weeks or more Weighing 2 kg or more Occurrence of neonatal seizures between the first day and the 28th day after birth Consent of the baby's parents or legal guardian 1 day 28 days Both Receiving anti convulsion drugs in the last 72 hours Seizures due to hypocalcemia, hypoglycemia, hypomagnesemia, and other electrolyte disorders Serum creatinine level greater than 1.6 mg / dL P90 Convulsions of newborn Treatment - Drugs Treatment - Drugs Intervention group: Patients are treated with levetiracetam injection (500 mg / 5ml by Estragen Company, Switzerland) at a loading dose of 50 mg/kg and infusion rate of 2 mg/kg/min (within 10 Cc of normal saline) under cardiorespiratory monitoring. If seizures continue with the first dose of levetiracetam, the drug is re-loaded at a dose of 50 mg/kg by the same infusion rate (within 10 cc of normal saline). If the seizure does not stop or returns after 15 minutes, even after the second dose of medication, the treatment groups are changed. If the seizure does not stop or returns after 15 minutes after changing treatment groups, other anticonvulsant drugs are used. Control group: Patients in the control group are treated with Phenobarbital injection (200mg/ml from Chemidarou company) at a loading dose of 20 mg/kg and at an infusion rate of 1 m/kg/min (within 10 Cc of normal saline) under cardiorespiratory monitoring,If the seizure continues with the first dose, phenobarbital is re-loaded by infusion at a dose of 20 mg per kg at the same rate as before. If the seizure does not stop or returns after 15 minutes, even after the second dose of medication, the treatment groups are changed. If the seizure does not stop or returns after 15 minutes after changing treatment groups, other anticonvulsant drugs are used. Complete cessation of seizures for 24 hours after medication. Timepoint: In the first 24 hours after medication. Method of measurement: Stopping seizure movements clinically (clinical assessment). Number of doses received to stop seizures. Timepoint: In the first 24 hours after medication. Method of measurement: Patient medical record. Reduce irritability. Timepoint: Before and after intervention. Method of measurement: Daily clinical examination and parental observations. Reduce anorexia. Timepoint: Before and after intervention. Method of measurement: Daily clinical examination and parental observations. Hamedan University of Medical Sciences Approved 2020-11-07 Research Ethic Committee of Hamadan University of Medical Sciences Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmide street Hamadan Hamadan Iran (Islamic Republic of)