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Evaluation of the effectiveness of topiramate in comparison with acetazolamide in ‎children with external hydrocephalus

Protocol summary

Study aim
Determination of the efficacy of topiramate in comparison with acetazolamide in mean and standard deviation of infant head circumference with external hydrocephalus
Design
A clinical trial study, with parallel groups, randomized into two age-matched groups on 50 infants between 3 and 9 months of age with external hydrocephalus
Settings and conduct
The study was performed on 50 infants with external hydrocephalus who referred to Shahid Beheshti Hospital in Kashan and Qom Children and were definitively diagnosed by clinical examination, head circumference measurement and sonography. At first, 2 weeks Given the opportunity and acceleration of growth around infants, if they are abnormal, they will be treated. Patients are divided into two groups. The first group received acetazolamide from Iran Daru Company and the second group received topiramate from Sobhan Company. At the end of each month, the head circumference is measured, and at the end of the 2-month treatment period, patients undergo Brain Sonography. One month after the end of the 2-month drug intervention, patients are evaluated for external hydrocephalus.
Participants/Inclusion and exclusion criteria
Inclusion criteria are normal development and criteria for diagnosing external hydrocephalus based on clinical evidence and imaging studies and negation of other major causes of head circumference (no brain tumor, internal hydrocephalus, subdural hematoma and symptoms of increased ICP). Exclusion criteria: having a brain tumor and subdural hematoma, symptoms of increased intracranial pressure, Abnormal cognitive motor development, the presence of internal hydrocephalus
Intervention groups
The first group receives acetazolamide from Iran Daru Company and the second group receives topiramate from Sobhan Company
Main outcome variables
Head circumference, motor developmental status, fontanel size, fontanel position, case group

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201105049278N1
Registration date: 2021-02-01, 1399/11/13
Registration timing: retrospective

Last update: 2021-02-01, 1399/11/13
Update count: 0
Registration date
2021-02-01, 1399/11/13
Registrant information
Name
Hosein Mahmoudzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5550 0111
Email address
mahmoudzadeh-h@mail.kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of topiramate in comparison with acetazolamide in ‎children with external hydrocephalus
Public title
The effectiveness of topiramate in comparison with acetazolamide in ‎children
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Being between 3 and 9 months old Final diagnosis of external hydrocephalus based on clinical evidence and brain imaging Normal status of cognitive motor development (based on interview and clinical examination)
Exclusion criteria:
Having a brain tumor and subdural hematoma Symptoms of increased intracranial pressure Abnormal cognitive motor development Existence of internal hydrocephalus
Age
From 3 months old to 9 months old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
A study on 50 infants with external hydrocephalus who referred to Shahid Beheshti Hospital in Kashan and Qom Children and were randomly divided into 2 groups of 25 blocks. In this method, it was done randomly by flipping the card. In this method, a number of cards or letters selected by the researcher as the first group and the same number of cards for the next groups are considered; Then, by merging the cards together (flipping the cards), a card is taken out and its allocation is recorded. The cards are then merged again and another card is removed. This process continues until a random sequence is reached according to the sample size (25 pieces).
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 in Research, School of Medicine and Dentistry, Kashan University of Medical Science
Street address
Kashan - Qutb Ravandi Boulevard - Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2020-09-08, 1399/06/18
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1399.094

Health conditions studied

1

Description of health condition studied
External hydrocephalus
ICD-10 code
G91.9
ICD-10 code description
Hydrocephalus, unspecified

Primary outcomes

1

Description
External hydrocephalus
Timepoint
At the end of each month, the head circumference is measured and at the end of the 2-month treatment period, patients undergo Brain Sonography, and one month after the end of the 2-month drug intervention, patients are evaluated for external hydrocephalus.
Method of measurement
Brain Sonography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: Acetazolamide from Iran Daroo Company (receiving 20 mg per kg of infant weight daily in two divided doses for 2 months)
Category
Treatment - Drugs

2

Description
Intervention group: Intervention group: Topiramate from Sobhan Company (receiving topiramate at the rate of 5 mg per kg body weight of the infant daily and in two divided doses for 2 months)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Kashan
Full name of responsible person
Hosein Mahmoudzadeh
Street address
Kashan - Qutb Ravandi Boulevard - Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5550 0111
Email
mahmoudzadeh-h@mail.kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Ahmad Talebian
Street address
Kashan - Qutb Ravandi Boulevard - Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5550 0111
Email
mahmoudzadeh-h@mail.kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Hosein Mahmoudzadeh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Kashan - Qutb Ravandi Boulevard - Kashan University ‎of Medical Sciences
City
Kashan ‎
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5550 0111
Email
mahmoudzadeh-h@mail.kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hosein Mahmoudzadeh
Position
Residency
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Kashan - Qutb Ravandi Boulevard - Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5550 0111
Fax
Email
mahmoudzadeh-h@mail.kaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hosein Mahmoudzadeh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Kashan - Qutb Ravandi Boulevard - Kashan University ‎of Medical Sciences
City
Kashan ‎
Province
Isfehan
Postal code
‏8715988141
Phone
+98 31 5550 0111
Email
mahmoudzadeh-h@mail.kaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Some data, such as information about the main outcome, can be shared
When the data will become available and for how long
Access period 2 months after printing the results
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
To prevent diseases and conduct similar studies
From where data/document is obtainable
Author
What processes are involved for a request to access data/document
By email
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