Background
Breath holding spell is a type of syncope in which loss of consciousness may happen due to injury, fear, anger or frustration. No treatment for this illness has been offered yet. In this study, we evaluated the effect of Piracetam in controlling breath-holding spells (BHS) and its effect on controlling the symptoms of the disease.
Methods
The study was a double blind randomized clinical trial. Sixty one volunteer children with BHS from Bu- Ali hospital of Ardabil were recruited with Inclusion criteria: 1)Parental consent for participation in the plan 2) Normal EEG 3) absent of systematic disease 4) Normal growth and Development 5) History of breath- Holding spell and physical and neurological examination by pediatric neurologist. 6) No Electrolyte Abnormality (Hypoglycemia and Hypocalcaemia ) Exclusion criteria: 1) Children with history of convulsion 2) Children that received Anticonvulsant drugs. 3) Delayed neurotic development 4) all Children with heart diseases 5) all children with anemia 6) Side effects of priacetam including true dizziness, convulsion, extra pyramidal sings, lethargy, headache, and sleepiness. Subjects were randomly allocated into two groups. The first group received Piracetam suspension (40 mg/kg twice a day), and the second group received placebo. Over 6 months, the patients were evaluated every 2 months .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010054872N1
Registration date:2010-12-09, 1389/09/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-12-09, 1389/09/18
Registrant information
Name
Aziz Kamran
Name of organization / entity
Lorestan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 912 623 4535
Email address
akamrani@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardebil University of Medical Sciences
Expected recruitment start date
2007-04-30, 1386/02/10
Expected recruitment end date
2008-03-29, 1387/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Can Piracetam control breath-holding spells and the symptoms of disease in children? A double blind RCT
Public title
A comparative study of piracetam effect
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1)Parental consent for participation in the plan 2) Normal EEG 3) absent of systematic disease 4) Normal growth and Development 5)History of breath- Holding spell and physical and neurological examination by pediatric neurologist. 6) No Electrolyte Abnormality (Hypoglycemia and Hypocalcaemia ) Exclusion criteria: 1) Children with history of convulsion 2) Children that received Anticonvulsant drugs. 3) Delayed neurotic development 4) all Children with heart diseases 5) all children with anemia 6) Side effects of priacetam including true dizziness, convulsion, extra pyramidal sings, lethargy, headache, sleepiness; gastrointestinal complication including nausea and vomiting, diarrhea, constipation, anorexia, increased weight
Age
From 1 year old to 14 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
61
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee in Ardebil University of Medical Sciences
Street address
Ardebil University of Medical Sciences
City
Ardebil
Postal code
Approval date
2008-02-02, 1386/11/13
Ethics committee reference number
6568
Health conditions studied
1
Description of health condition studied
breath holding spell
ICD-10 code
R06.8
ICD-10 code description
Other and unspecified abnormalities of breathing
Primary outcomes
1
Description
interval time between BHS
Timepoint
before prevention and every 2 month in 6 month
Method of measurement
questionnaire & exam
2
Description
BHS duration
Timepoint
before prevention and every 2 month in 6 month
Method of measurement
Filling a questionnarie by asking questions from parents & exam
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: administration of piracetam in 6 mounth period with dose of 40/mg/kg/day
Category
Treatment - Drugs
2
Description
contorol group: administration of placebo in 6 mounth period
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Hospitals in the Imam Khomeini and BoAli
Full name of responsible person
Dr Mehrdad Mirzarahimi
Street address
City
Ardebil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardeabil University of Medical Sciences.
Full name of responsible person
Dr Mehrdad Mirzarahimi
Street address
Faculty of Medicine. Pediatrics Department
City
Ardebil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardeabil University of Medical Sciences.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ardebil University of Medical Sciences
Full name of responsible person
Dr Mehrdad Mirzarahimi
Position
Pediatrician, Neonatalogist
Other areas of specialty/work
Street address
Ardebil University of Medical Sciences
City
Ardebil
Postal code
Phone
+98 914 452 6802
Fax
Email
mirzarahimim@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
community medicine department, medicine faculty, Ardebil University of Medical Sciences, iran
Full name of responsible person
Dr. Afshan Sharghi
Position
Specialist of community medicine
Other areas of specialty/work
Street address
Ardebil University of Medical Sciences
City
Ardebil
Postal code
Phone
+98 914 452 6802
Fax
Email
mirzarahimim@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
ardebil university of Medical sciences
Full name of responsible person
َAziz Kamran
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)