1-Objectives: To determine the effect of treatment with high and low dose of ACTH in patients with infantile spasms in terms of number of seizures, Hospitalization, medications, side effectes and short-term prognosis.
2- design: The study is single center. sample size 30 infants with infantile spasms, they were divided into two groups with high and low dose of ACTH thrapy.
Randomized single blind study.
3- setting and conduct: After the treatment of patients during 18 months we follow up of the objectives of the study.
4- participants: Infant with infantile spasm with consent of parent to start treatment .
5-Intervention: Ampul ACTH 10 mg , 0/1 mg and 0/25 mg injection
6-Primary and secondary outcome variables: Number of seizures, Hospitalization, medications, side effectes and short-term prognosis, blood glocose and blood pressure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015060110634N2
Registration date:2016-02-09, 1394/11/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-09, 1394/11/20
Registrant information
Name
Afshin Fayazi
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0075
Email address
afshin_fay@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamedan University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative of high dose and low dose adrenocorticotropic hormone (ACTH) therapy for infantile spasm
Public title
A Comparative of high dose and low dose adrenocorticotropic hormone (ACTH) therapy for infantile spasm
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: infant with infantile spasm
exclusion criteria:
1-cancel from participation in research
2-Lack of consent to start therapy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Randomization was performed by blocking .
Secondary Ids
1
Registry name
N/A
Secondary trial Id
N/A
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of hamedan University of Medical Sciences
Street address
Univercity of medical sciences, Pajoohesh crossroad, Hamedan city, Iran
City
Hamedan
Postal code
Approval date
2015-01-17, 1393/10/27
Ethics committee reference number
16/35/9/5432
Health conditions studied
1
Description of health condition studied
Infantile spasm
ICD-10 code
G40.4
ICD-10 code description
Other generalized epilepsy and epileptic syndromes
Primary outcomes
1
Description
Count of seizure
Timepoint
6 months later intervention
Method of measurement
Clinical scale
2
Description
Hospitalization duration
Timepoint
6 months later intervention
Method of measurement
day
3
Description
Demands of other drugs
Timepoint
6 months later intervention
Method of measurement
Clinical scale
4
Description
Prognosis
Timepoint
6 months afterr intervention
Method of measurement
Clinical veiw
Secondary outcomes
1
Description
Hypoglycemia
Timepoint
6 months after intervention
Method of measurement
glocometry
2
Description
Blood pressure
Timepoint
6 months afterr intervention
Method of measurement
Manometr
Intervention groups
1
Description
Intervention group: ACTH injection Ampul 10 mg / 0/25 mg/ novartis products/ According to PRrotocol of study for 6 months.
Category
Treatment - Drugs
2
Description
Control group: ACTH Ampul injection 10 mg/ 0/1 mg According to Protocol of study for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Samira Mokhtari
Street address
Motahharo bulvar, Resalat sequre,Hamedan city, Iran
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Hamedan Univercity of Medical Sciences
Full name of responsible person
Mohammad taghi Goodarzi
Street address
Hamedan Univercity of Medical Sciences, Pajoohesh crossroads, Hamedan, Iran
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Hamedan Univercity 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
Hamedan University of Medical Sciences
Full name of responsible person
Samira Mokhtari
Position
Pediatric Rezident
Other areas of specialty/work
Street address
Unit 2, Nomber 13, Ghahremani lane, 72 sequre, Narmak, Tehran city, Iran
City
Tehran
Postal code
Phone
+98 21 7790 9733
Fax
Email
s.mokhtari63@gmail.com;afshin_fay@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Samira Mokhtari
Position
Pediatric Rezident
Other areas of specialty/work
Street address
Unit 2, Nomber 13, Ghahremani lane, 72 sequre, Narmak, Tehran city, Iran
City
Tehran
Postal code
Phone
+98 21 7790 9733
Fax
Email
s.mokhtari63@ gmail.com; Afshin_fay@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Samira mokhtari
Position
pediatric rezident
Other areas of specialty/work
Street address
Unit 2, Nomber 13, Ghahremani lane, 72 sequre, Narmak, Tehran city, Iran
City
tehran
Postal code
Phone
Fax
Email
s.mokhtari63@gmail.com; Afshin_fay@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)