Comparison of the effect of levetiracetam and piracetam on the treatment of severe breath holding spells in children aged 6 months to 6 years in 2019
Design
Randomized, non-blinded, controlled clinical trial with parallel groups
Settings and conduct
This study starts in the winter of 1397 by selecting 64 patients from the patients referred to the Neurology Clinic of Imam Hossein Hospital. They are randomly assigned to two groups.
Participants/Inclusion and exclusion criteria
inclusion criteria: Patients with BHS attacks at least 3 times a month, less than 6 years of age and above 6 months, normal growth and development, normal cardiac, cerebral and neurological examinations, electrolyte impairment, hypoglycemia and iron deficiency, lack of history of any seizure or neurological problem or epilepsy
Exclusion criteria: inability to follow up, existence of drug reaction or any other problem, seizure or any neurological disorders during the study
Intervention groups
Patients (depending on the group in which they are treated) are treated with levetiracetam with a dose of 40 mg / kg / day and second group is treated with piracetam 100 mg / kg for 3 months.
Main outcome variables
The number and severity of the attacks before the start of treatment and monthly up to three months later
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190208042654N1
Registration date:2019-05-27, 1398/03/06
Registration timing:registered_while_recruiting
Last update:2019-05-27, 1398/03/06
Update count:0
Registration date
2019-05-27, 1398/03/06
Registrant information
Name
Vahid Mansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 3653
Email address
v.mansoury@edc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-16, 1397/12/25
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Levetiracetam and Piracetam efficacy on severe Breath Holding Spells; A Randomized Controlled clinical trial
Public title
The Comparison of Levetiracetam and Piracetam efficacy on severe Breath Holding Spells
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with severe breath holding attacks at least 3 times a month
Aged less than 6 years and more than 6 months
Normal growth and development
Normal cardiovascular, cerebral and neurological examinations
Not having electrolyte disturbances, hypoglycemia and iron deficiency
Not having any seizure or neurological problem or epilepsy
Exclusion criteria:
Inability to follow up
occurrence of any drug reaction or any other problem during treatment
occurrence of seizure or any neurological disorders during the study
Age
From 6 months old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 64 patients will be selected consecutively, if they meet the criteria for entry, from the patients admitted to the neurology clinic of Imam Hossein children hospital. Then, they are assigned randomly to two groups by binary blocks. The randomization process is done by using a random numbered table to reach the desired sample number.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-03-12, 1397/12/21
Ethics committee reference number
IR.MUI.MED.REC.1397.333
Health conditions studied
1
Description of health condition studied
Breath holding spell
ICD-10 code
R06.8
ICD-10 code description
Other abnormalities of breathing
Primary outcomes
1
Description
Number of breath holding spells
Timepoint
Before the intervention and monthly up to 3 months
Method of measurement
Questionnaire
2
Description
Severity of breath holding spells: Percentage of convulsive attacks
Timepoint
Before the intervention and monthly up to 3 months
Method of measurement
Questionnaire
Secondary outcomes
1
Description
EEG pattern
Timepoint
Before the intervention and 3 months later
Method of measurement
Electroencephalography
Intervention groups
1
Description
Intervention group: Levetiracetam: For 3 months, they are treated with Levetiracetam (100 mg/ml) with a dose of 40 mg/kg/day. Changes in the number of attacks and the percentage of convulsive attacks will be assessed during the three months.
Category
Treatment - Drugs
2
Description
Control group: Piracetam: They are treated with piracetam 100 mg/kg for 3 months. Changes in the number of attacks and the percentage of convulsive attacks will be assessed during the three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein Hospital
Full name of responsible person
Mohammad Mehdi Salehi
Street address
Emam Khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 8247
Email
F_peiravi_isfahani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Hezar jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad reza Ghazavi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Emam Khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
ghazavi8147@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad reza Ghazavi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Emam Khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
ghazavi8147@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad reza Ghazavi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Emam Khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
ghazavi8147@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available