Comparison of efficacy and safety of levetiracetam and phenobarbital in controlling neonatal seizures
Design
A clinical trial with a control group with a parallel-group design, double-blind; randomized; Phase 2-3, on 40 patients. Block randomization method will be used for randomization.
Settings and conduct
The design will be a double-blinded controlled clinical trial (Parents of infants and the person who fills out the questionnaires) which is due to the uniform form of the drug which will be done in the NICU of Besat Hospital in Hamadan in 2022. Infants under 1 month of age with a gestational age of 36 weeks admitted to the NICU due to seizures are included in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 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.
Exclusion criteria: 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
Intervention groups
Intervention group: The patients are treated with levetiracetam injection (500 mg / 5ml, produced by STRAGEN pharmaceutical company) 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. Control group: Patients are treated with Phenobarbital injection (200mg/ml, produced by 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.
Main outcome variables
No seizures for 24 hours after medication; Number of doses received to stop seizures; Side effects such as irritability and anorexia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160523028008N23
Registration date:2022-06-13, 1401/03/23
Registration timing:registered_while_recruiting
Last update:2022-06-13, 1401/03/23
Update count:0
Registration date
2022-06-13, 1401/03/23
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-05, 1401/02/15
Expected recruitment end date
2022-07-06, 1401/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and safety of Levetiracetam and Phenobarbital in controlling neonatal seizures
Public title
The effect of levetiracetam and phenobarbital on the control of neonatal seizures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 1 day old to 28 days old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmide street
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-11-07, 1399/08/17
Ethics committee reference number
IR.UMSHA.REC.1399.681
Health conditions studied
1
Description of health condition studied
Convulsions of newborn
ICD-10 code
P90
ICD-10 code description
Convulsions of newborn
Primary outcomes
1
Description
Complete cessation of seizures for 24 hours after medication
Daily clinical examination and parental observations
2
Description
Reduce anorexia
Timepoint
Before and after intervention
Method of measurement
Daily clinical examination and parental observations
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Nader Faraji
Street address
Fatemi Blvd.
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0064
Email
naderfaraji59@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokohei
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nader Faraji
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Fatemi Blvd.
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 912 248 3658
Email
naderfaraji59@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nader Faraji
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Fatemi Blvd.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 917 332 4977
Email
naderfaraji59@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohamad Kazem Sabzehei
Position
Neonatologist- assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Fatemi Blvd.
City
Hamadan
Province
Hamadan
Postal code
+98 81 3838 0717
Phone
+98 917 332 4977
Email
Mk_sabzehei@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD