Our objective was to determine the efficacy of Piracetam on the treatment of breath holding spells. Inclusion criteria: 1- History of breath- Holding spell 2- minimum age 6 month and maximum 3 years old 3- Normal EEG3 4- absent of systematic disease 5- Normal growth and Development 6- No history of epilepsy in family members 7- No Electrolyte Abnormalities (Hypoglycemia & 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. Hundred patients with Breath Holding spell were randomized in two groups. First group received placebo and the other received 40 mg/kg/day priacetam. Then we evaluated the number of breath holding spell before intervention, 2 weeks and 2 month after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138801231808N1
Registration date:2009-06-29, 1388/04/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-06-29, 1388/04/08
Registrant information
Name
Ali Abbaskhanian
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1223 3010
Email address
aabbaskhanian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences and Health Services
Expected recruitment start date
2009-04-15, 1388/01/26
Expected recruitment end date
2009-06-22, 1388/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Efficacy of Piracetam on the Treatment of Breath _Holding Spells
Public title
Clinical Efficacy of Piracetam on the Treatment of Breath _Holding Spells
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) History of breath- Holding spell and physical and neurological examination by pediatric neurologist. 2) Minimum age 6 month and maximum 3 years old 3) Normal EEG 4) absent of systematic disease 5) Normal growth and Development 6) No history of epilepsy in family member 7) 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, sleepy; gastrointestinal complication including nausea and vomiting, diarrhea, constipation, anorexia, increased weight
Age
From 1 year old to 3 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Mazandaran University of Medical Sciences and Health Services
Street address
Imam Sq, Joybar 3way, Start of valiye asr highway
City
Sari
Postal code
Approval date
empty
Ethics committee reference number
88-9
Health conditions studied
1
Description of health condition studied
Breath-holding spells
ICD-10 code
R06.8
ICD-10 code description
Other and unspecified abnormalities of breathing
Primary outcomes
1
Description
the number of Breath-holding spell
Timepoint
before prevention and 2 weeks after prevention
Method of measurement
questionarie of parents
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: administration of piracetam in 2 mounth period with dose of 40/mg/kg/day
Category
Treatment - Drugs
2
Description
contorol group: administration of placebo in 2 mounth period
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bouali sina hospital - pediateric Department
Full name of responsible person
Ali Abbaskhanian
Street address
Emam sq - Pasdaran Blv
City
Sari
2
Recruitment center
Name of recruitment center
Tuba clinic
Full name of responsible person
Ali Abbaskhanian
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences and Health Services
Full name of responsible person
Ali Abbaskhanian
Street address
Boalisina hospital, pediateric department - Imam sq - Pasdaran Blv
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences and Health Services
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
Mazandaran Univercity of Medical sciences and Health ervices