Comparing the therapeutic efficacy of intravenous Levetiracetam (Matever) and phenobarbital as first-line treatment for neonatal seizures in Bahrami Hospital
Design
A Block-randomized, double-blinded controlled clinical trial on 44 neonates
Settings and conduct
Neonates, either term or preterm, with neonatal seizure manifestations who were referred to Bahrami Hospital in Tehran between 2019-2020 were included in this study. Patients were randomly categorized into two groups, one receiving Phenobarbital and the other Levetiracetam as the initial seizure management medication. Seizure control and prevention of seizure repeats were compared between the two groups in 48 hours. Informed consent was obtained from the patients' parents or legal guardians.
Participants/Inclusion and exclusion criteria
Neonates with neonatal seizure manifestations were included in this study. Patients with hepatic dysfunction; renal dysfunction; or lack of consent were excluded.
Intervention groups
Administration of intravenous levetiracetam as the first-line medication for neonatal seizure control and prevention of seizure recurrence within 48 hours. Intravenous form of phenobarbital was used for the control group.
Main outcome variables
seizure control comparison
Prevention of seizure repeats comparison
General information
Reason for update
Acronym
LPNS
IRCT registration information
IRCT registration number:IRCT20220410054471N1
Registration date:2023-07-26, 1402/05/04
Registration timing:retrospective
Last update:2023-07-26, 1402/05/04
Update count:0
Registration date
2023-07-26, 1402/05/04
Registrant information
Name
kamyar kamrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2292 1930
Email address
k_kamrani@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
2019-03-21, 1398/01/01
Actual recruitment end date
2021-03-20, 1399/12/30
Trial completion date
2021-03-20, 1399/12/30
Scientific title
Comparing the therapeutic efficacy of intravenous Levetiracetam and phenobarbital as first-line treatment for neonatal seizures
Public title
Comparing Levetiracetam and phenobarbital as first-line treatment for neonatal seizures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Neonates with seizure manifestations
Exclusion criteria:
Renal impairment
Lack of consent
Age
To 28 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
44
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed using the block randomization technique using 4 and 6 allele blocks. Using blocks consisting of A, and B alleles, 4- and 6- allele structures like AAAA, and ABBA, etc. were formed and were randomly allocated to each patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
The subjects of this study are neonates; thus they do not know which group they are being allocated to, and moreover, the researcher does not know which neonate is receiving which drug. As a result, this study can be considered double blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Ghods Ave. crossing, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2020-11-14, 1399/08/24
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.747
Health conditions studied
1
Description of health condition studied
Neonatal seizure
ICD-10 code
P90
ICD-10 code description
Convulsions of newborn
Primary outcomes
1
Description
seizure control
Timepoint
48 hours
Method of measurement
clinical
2
Description
seizure recurrence control
Timepoint
48 hours
Method of measurement
Clinical
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Bolus Intravenous Levetiracetam (Matever) with a 20 mg/kg dose as initial therapy
Category
Treatment - Drugs
2
Description
Control group: Bolus Intravenous phenobarbital with a 20 mg/kg dose as initial therapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahrami Hospita;
Full name of responsible person
Kamyar Kamrani
Street address
Kiani Str., Damavand Ave., Emam Hossein sqr
City
Tehran
Province
Tehran
Postal code
1641744991
Phone
+98 21 7301 3000
Email
K_kamrani@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Qods Ave. Crossing, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Kamyar Kamrani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Kiani Str., Damavand Ave., Emam Hossein sqr
City
Tehran
Province
Tehran
Postal code
1641744991
Phone
+98 21 7301 3000
Email
K_kamrani@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kamyar Kamrani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Kiani Str., Damavand Ave., Emam Hossein sqr
City
Tehran
Province
Tehran
Postal code
1641744991
Phone
+98 21 7301 3000
Email
K_kamrani@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kamyar Kamrani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Kiani Str., Damavand Ave., Emam Hossein sqr
City
Tehran
Province
Tehran
Postal code
1641744991
Phone
+98 21 7301 3000
Email
K_kamrani@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
In this study, data will be sharable after making it anonymous, upon request
When the data will become available and for how long
Data can be shared, 3 months following publication upon request
To whom data/document is available
University and research centers researchers can use the shared data
Under which criteria data/document could be used
The data will be shared with researchers for research and academic purposes.
From where data/document is obtainable
Access to data will be through the correspondent author by email communication
What processes are involved for a request to access data/document
Following submission for access to data, according to the correspondent judgment, the request will be assessed in a research team meeting, and if accepted, the data will be presented after becoming anonymous.