Comparison of the outcomes of neonatal seizure treatment with phenobarbital versus levetiracetam after discharge
Design
Clinical trial with control and parallel groups, double blind, randomized
Settings and conduct
This study will be performed on 60 infants with a gestational age of more than 36 weeks who were admitted to the neonatal intensive care unit of Ghaem Hospital due to seizures. Patients are randomly divided into two groups and at the time of discharge, one group is treated with phenobarbital and the other with levetiracetam. In this double-blind study, patients and outcome assessors are unaware of the type of grouping. Patients are evaluated for recurrence of seizures and growth and development at the time of discharge and also three and six months after discharge.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 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.
Exclusion criteria: Finding any errors of metabolism as the cause of seizures;
finding any structural abnormalities in the brain on magnetic resonance imaging of the brain or head ultrasound; gestational age is below 36 weeks;
congenital metabolic disorders
Intervention groups
Intervention group: Patients are treated with 30 mg/kg levetiracetam.
Control group: Patients are treated with 5 mg/kg phenobarbital.
Main outcome variables
Reoccurrence of seizures; newborn's growth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200131046317N3
Registration date:2021-08-25, 1400/06/03
Registration timing:prospective
Last update:2021-08-25, 1400/06/03
Update count:0
Registration date
2021-08-25, 1400/06/03
Registrant information
Name
Javad Akhondian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 7451
Email address
akhondianj@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-01, 1400/06/10
Expected recruitment end date
2022-06-11, 1401/03/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the outcomes of neonatal seizure treatment with phenobarbital versus levetiracetam after discharge
Public title
Comparison of the effects of phenobarbital and levetiracetam on neonatal seizure after discharge
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 1 day old to 1 month old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-01-19, 1399/10/30
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.208
Health conditions studied
1
Description of health condition studied
convulsion of newborn
ICD-10 code
P90
ICD-10 code description
Convulsions of newborn
Primary outcomes
1
Description
reoccurrence of seizures
Timepoint
3 and 6 months after discharge
Method of measurement
Based on parents' reports
2
Description
the newborn's growth
Timepoint
3 and 6 months after discharge
Method of measurement
Clinical observation
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Nazanin Saeidi Zand
Street address
Ghaem hospital, Ahmad Abad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2649
Email
dr.nazanin_zand@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Nazanin Saeidi Zand
Position
Student of sub specialist
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Ghaem Hospital, Ahmad Abad Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2496
Email
dr.nazanin_zand@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Javad Akhondian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ghaem hospital, Ahmad Abad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2496
Email
akhondianj@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nazanin Saeidi Zand
Position
Student of sub specialist
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Ghaem Hospital, Ahmad Abad Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2496
Email
dr.nazanin_zand@yahoo.com
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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible through an email to the corresponding author.
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes.
Under which criteria data/document could be used
Data can be accessible 6 months after results are published.
From where data/document is obtainable
After sending a request email to the corresponding author, data will be sent in 1 month.
What processes are involved for a request to access data/document