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IRCT20200528047589N1 IRCT 2020-09-08 Mashhad University of Medical Sciences Comparison of effects of phenobarbital and levetiracetam in neonatal seizure control Comparison of effects of phenobarbital and levetiracetam in the control of neonatal seizure 2020-08-22 anticipated 74 Complete https://irct.ir/trial/48567 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: We use Stata software for random allocation. Blocks of 4, 6 and 8 are used to make the concealment unpredictable. After entering and obtaining informed consent, patients are evaluated for eligibility and then it is determined to which group they are assigned according to the determined sequences, Blinding description: According to randomization, the patient is assigned into one of the control or intervention groups. The drug is prepared at the drug preparation site 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 and 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. 3 Neonatal seizures. Intervention 1: In the intervention group, patients are treated with levetiracetam injection (500 mg / 5ml STRAGEN pharmaceutical company) at a loading dose of 30 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 20 mg / kg by the same infusion rate (within 10 cc of normal saline). Then, in case of seizure control, after 24 hours, treatment will be continued with phenobarbital at a dose of 5 mg / kg / day divided every 12 hours and lutiracetam at a dose of 40 mg / kg / day in 2 divided doses every 12 hours, respectively. (Injection rate and method will be similar to loading doses.) In case of non-control of seizures with the first drug, phenytoin ampoule (250 mg / 5ml of Tamin company) as a second-line drug at a loading dose of 20 mg / kg with infusion rate of 1 mg / kg / min (within 10 cc of normal saline) will be used and maintenance treatment with phenytoin at a dose of 5 mg / kg / day will be continued every 12 hours at the same infusion rate. If seizures persist after administration of second-line medication, the Midazolam will be injected at a loading dose of 0.15 mg / kg and then continued with a drop of 1 μg / kg / min. The initial intervention is within 15 minutes of drug administration and the more intervention depends on seizure control. Thus, the total duration of intervention depends on the response of the infant and varies from infant to infant. Intervention 2: In the control group, patients are treated with ampoules of Phenobarbital (200mg/ml from Chemidarou company) at a loading dose of 20 mg/kg and at the infusion rate of 1 m/kg/min (within 10 Cc of normal saline) under cardiorespiratory monitoring. If seizures continue with the first dose, the drug is re-loaded at a dose of 10 mg/kg by the same infusion rate (within 10 cc of normal saline). Then, in case of seizure control, the infusion will be continued 24 hours later at the same rate at a maintenance dose of 5 mg / kg / day in 2 divided doses every 12 hours. In case of non-control of seizures with the first drug, phenytoin ampoule (250 mg/5ml of Tamin company) as the second-line drug at a loading dose of 20 mg / kg and at the infusion rate of 1 mg / kg / min (within 10 cc of normal saline) will be used and maintenance treatment with infusion of phenytoin at a dose of 5 mg / kg / day will be continued every 12 hours at the same rate. If seizures persist after administration of second-line medication, the Midazolam will be injected at a dose of 0.15 mg / kg and then continued with a drop of 1 μg / kg / min. The initial intervention is within 15 minutes of drug administration and the more intervention depends on seizure control. Thus, the total duration of intervention depends on the response of the infant and varies from infant to infant. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Gholam ali Maamouri
Ghaem Hospital, Ahmadabad St
Mashhad Iran (Islamic Republic of) 91766-99199 +98 51 3841 2069 MaamouriGh@mums.ac.ir Mashhad University of Medical Sciences scientific Gholam ali Maamouri
Ghaem Hospital, Ahmadabad St.
Mashhad Iran (Islamic Republic of) 91766-99199 +98 51 3841 2069 MaamouriGh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) pregnancy age of 34 weeks or more Weight of greater than or equal to 2 kg Hospitalization due to seizure of unknown cause in the pediatric emergency room or neonatal intensive care unit no limit 1 month Both underlying anomaly Systemic metabolic disease Structural disorders of the brain Previous history of anticonvulsant medication Presence of drug allergies including urticaria, flushing, angioedema, anaphylaxis P90 Convulsions of newborn Prevention Prevention In the intervention group, patients are treated with levetiracetam injection (500 mg / 5ml STRAGEN pharmaceutical company) at a loading dose of 30 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 20 mg / kg by the same infusion rate (within 10 cc of normal saline). Then, in case of seizure control, after 24 hours, treatment will be continued with phenobarbital at a dose of 5 mg / kg / day divided every 12 hours and lutiracetam at a dose of 40 mg / kg / day in 2 divided doses every 12 hours, respectively. (Injection rate and method will be similar to loading doses.) In case of non-control of seizures with the first drug, phenytoin ampoule (250 mg / 5ml of Tamin company) as a second-line drug at a loading dose of 20 mg / kg with infusion rate of 1 mg / kg / min (within 10 cc of normal saline) will be used and maintenance treatment with phenytoin at a dose of 5 mg / kg / day will be continued every 12 hours at the same infusion rate. If seizures persist after administration of second-line medication, the Midazolam will be injected at a loading dose of 0.15 mg / kg and then continued with a drop of 1 μg / kg / min. The initial intervention is within 15 minutes of drug administration and the more intervention depends on seizure control. Thus, the total duration of intervention depends on the response of the infant and varies from infant to infant. In the control group, patients are treated with ampoules of Phenobarbital (200mg/ml from Chemidarou company) at a loading dose of 20 mg/kg and at the infusion rate of 1 m/kg/min (within 10 Cc of normal saline) under cardiorespiratory monitoring. If seizures continue with the first dose, the drug is re-loaded at a dose of 10 mg/kg by the same infusion rate (within 10 cc of normal saline). Then, in case of seizure control, the infusion will be continued 24 hours later at the same rate at a maintenance dose of 5 mg / kg / day in 2 divided doses every 12 hours. In case of non-control of seizures with the first drug, phenytoin ampoule (250 mg/5ml of Tamin company) as the second-line drug at a loading dose of 20 mg / kg and at the infusion rate of 1 mg / kg / min (within 10 cc of normal saline) will be used and maintenance treatment with infusion of phenytoin at a dose of 5 mg / kg / day will be continued every 12 hours at the same rate. If seizures persist after administration of second-line medication, the Midazolam will be injected at a dose of 0.15 mg / kg and then continued with a drop of 1 μg / kg / min. The initial intervention is within 15 minutes of drug administration and the more intervention depends on seizure control. Thus, the total duration of intervention depends on the response of the infant and varies from infant to infant. Control of seizures after drug injection. Timepoint: 15 minutes after administration of the drug in cases of seizures and within 24 hours in cases where the seizures have stopped. Method of measurement: Stoping seizure movements clinically. The need or lack of need to continue anticonvulsant medication at discharge. Timepoint: at the time of discharge. Method of measurement: Diagnosis of the treating physician. Mashhad University of Medical Sciences Approved 2020-06-16 Ethics Committee of Mashhad University of Medical Sciences Central Organization of Mashhad University of Medical Sciences, Daneshgah street ,Mashhad,Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)