The aim of this study is evaluation of therapeutic effects of piracetam in single daily dose in compare with twice daily dose of 40mg/kg/day for treatment of severe spells.
Inclusion criteria: Age of 6 months to three years; Frequent seizures more than two times a week; Severe seizures that lead to loss of consciousness. Exclusion criteria: History of seizures; History of heart disease; Anemia (hemoglobin less than 10.5).
In this prospective clinical trial, children with severe BHS will be referred to our outpatient university clinics of pediatric neurology and will be randomized to single dose and dividing doses groups.
Control group (Single dose) will receive single daily dose of 40mg/kg/day piracetam in the morning and intervation group (dividing dose) will receive 20mg/kg/dose of piracetam twice daily. Patients will be followed for four months. The number of severe attacks before and after treatments will be recorded.
The data will be analyzed.
All patients will fill in informed consent .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060612782N11
Registration date:2017-03-10, 1395/12/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-10, 1395/12/20
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effects of single and divided dose of piracetam in patients with breath holding spells
Public title
Therapeutic effects of single and divided doses of piracetam for children with breath holding spells
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria for the study included as follows:
Age of 6 months to three years; Frequent seizures, more than two times a week; Severe seizures that lead to loss of consciousness
Exclusion criteria included as follows:
History of seizures; History of heart disease; Anemia (hemoglobin less than 10.5)
Age
From 6 months old to 3 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
Isfahan university of medical sciences, azadi square, Isfahan, Iran
City
isfahan
Postal code
81746-73461
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.MUI.REC.1394.30814
Health conditions studied
1
Description of health condition studied
breath holding
ICD-10 code
R06.8
ICD-10 code description
Other and unspecified abnormalities of breathing
Primary outcomes
1
Description
number of breath holding
Timepoint
once in any month for 4 months
Method of measurement
ask from mother
Secondary outcomes
1
Description
drug side effects
Timepoint
once in any month for 4 months
Method of measurement
examamination and ask from mother
Intervention groups
1
Description
Control group: 40 mg/kg piracetam single dose daily
Category
Treatment - Drugs
2
Description
Intervention group: 40 mg/kg Piracetam in two doses every 12 hours