Comparison of the efficacy of Piracetam and probiotic-Piracetam in cyanotic breath holding spells in children
Design
Clinical trial with two parallel groups, without blindness, randomised, phase 2 on 58 patients, in block randomization method with the size of 4 and 6, Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/).
Settings and conduct
The aim of the study is comparison of the efficacy of Piracetam and probiotic-Piracetam in cyanotic breath holding spells in 58 children refer to Amirkabir hospital of Arak city. They will be devided into 2 groups (Piracetam or probiotic-Piracetam) randomly.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Children with cyanotic breath holding spells diagnosed by neurologist.
Children who have informed consent filling by their parents.
Non-inclusion criteria:
Children using corticosteroid drugs
Children with underlying disease such as cyanotic heart disease
Children with iron deficiency anemia
Intervention groups
In Piracetam group 55 mg/kg of Piracetam tablet and in Probiotic-Piracetam group both of 1 sachet of reuteflor (300 mg of liofilizate cells of Lactobacillus reuteri) and 55 mg/kg of Piracetam tablet will be given to children, daily for 1 month.
Main outcome variables
Frequency (number) of breath holding spells
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201028049175N8
Registration date:2021-05-30, 1400/03/09
Registration timing:prospective
Last update:2021-05-30, 1400/03/09
Update count:0
Registration date
2021-05-30, 1400/03/09
Registrant information
Name
Shamim Valibak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
sh.valibak@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Piracetam and probiotic-Piracetam in cyanotic breath holding spells in children
Public title
Comparison of the efficacy of Piracetam and probiotic-Piracetam in cyanotic breath holding spells in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with cyanotic breath holding spells diagnosed by neurologist
Children who have informed consent filling by their parents
Exclusion criteria:
Children using corticosteroid drugs
Children with underlying disease such as cyanotic heart disease
Children with iron deficiency anemia
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into two groups using a permuted balanced block randomization method with the size of blocks 4 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Concealment is also guaranteed due to the use of specific codes that are obtained by the website.
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 Arak University of Medical Sciences
Street address
Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Sardasht street
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2021-05-16, 1400/02/26
Ethics committee reference number
IR.ARAKMU.REC.1400.026
Health conditions studied
1
Description of health condition studied
Breath holding spells
ICD-10 code
R06.8
ICD-10 code description
Other abnormalities of breathing
Primary outcomes
1
Description
Frequency (number) of cyanotic breath holding spells
Timepoint
Daily
Method of measurement
Filling the questionnaire by the mother
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In Piracetam group 55 mg/kg of Piracetam tablet will be given to children, daily for 1 month.
Category
Treatment - Drugs
2
Description
Intervention group:In Probiotic-Piracetam group both of 1 sachet of Farabiotic Reuteflor (300 mg of liofilizate cells of Lactobacillus reuteri) and 55 mg/kg of Piracetam tablet will be given to children, daily for 1 month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr. Fakhredin Shariatmadari
Street address
Parastar square, Shiroudi street
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 4715
Email
info@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Assistance of research and technology of Arak university of medical science-Dr Alireza Kamali
Street address
Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Sardasht street
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Mojtaba Hashemi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Parastar square, Shiroudi street
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 4715
Email
mojtaba53hashemi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Fakhredin Shariatmadari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Parastar square, Shiroudi street
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 4715
Email
shariat.8666@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Shamim Valibak
Position
General physician non-faculty
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Valiasr hospital, Valiasr square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
0098 86 32222003-8
Email
sh.valibak@yahoo.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