The aim of this study is to comparie between Efficacy of Treatment With Propranolol in Newborns With Retinopathy of Prematurity and control. This is a Randomized Double blind Clinical Trial which will be conducted on 50 Premature patients (aged 23-31 weeks ) with the diagnosis of Retinopathy of Prematurity. Children with the diagnosis of Retinopathey Prematurity and lack of diseases such as any type of heart disease, low blood pressure, brain hemmorhage included in this study. Patients with severe complications of propranolol such as severe bradycardy or low blood pressure excluded. The Premature Neonates were assigned to A& B groups based on Random Blockings. Group A recieved oral Propranolol (2 mg/kg/day divided in 4 doses for 26-31 weeks and 1mg/kg/day divided in 4 doses for 23-25 weeks) plus routine treatment and Group B recieved only routine treatment based on Ophtalmologist recommendation. Infants will be assessed until final vascularization for each 2 weeks and the level of Retinopathyand the Success of Treatment will be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102524681N1
Registration date:2015-11-13, 1394/08/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-13, 1394/08/22
Registrant information
Name
Reza Sharafi
Name of organization / entity
Guilan University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 9002
Email address
rsharafi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
The Vice Chancellor of Research of Guilan University of Medical Sciences
Expected recruitment start date
2015-11-06, 1394/08/15
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between Efficacy of Treatment With Propranolol in Newborns With Retinopathy of Prematurity and control
Public title
The comparison between Efficacy of Treatment With Propranolol in Newborns With Retinopathy of Prematurity and control
Purpose
Prevention
Inclusion/Exclusion criteria
Children with the diagnosis of retinopathy prematurity and lack of diseases such as any type of heart disease; low blood pressure; brain hemmorhage included in this study. Patients with severe complications of propranolol such as severe bradycardy or low blood pressure excluded.
Age
No age limit
Gender
Both
Phase
2-3
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Guilan University of Medical Sciences, Namjoo Street
City
Rasht
Postal code
Approval date
2015-10-06, 1394/07/14
Ethics committee reference number
IR.GUMS.REC.1394.288
Health conditions studied
1
Description of health condition studied
Retinopathy of prematurity
ICD-10 code
H35.1
ICD-10 code description
Retinopathy of prematurity
Primary outcomes
1
Description
Grade of retinopathy
Timepoint
Each 2 weeks upto complete vascularization
Method of measurement
Grade of retinopathy 1-5
Secondary outcomes
empty
Intervention groups
1
Description
oral Propranolol (2 mg/kg/day divided in 4 doses for 26-31 weeks and 1mg/kg/day divided in 4 doses for 23-25 weeks) plus routine treatment
Category
Prevention
2
Description
outine treatment based on Ophtalmologist recommendation
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr Reza Sharafi
Street address
Namjoo Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Guilan University of Medical Sciences
Full name of responsible person
Dr Abtin Heidarzadeh
Street address
Guilan University of Medical Sciences, Gaz Square
City
Rasht
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, Guilan 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
Guilan University of Medical Science
Full name of responsible person
Dr Reza Sharafi
Position
Assistant Professor
Other areas of specialty/work
Street address
Guilan University of Medical Sciences, Namjoo Street
City
Rasht
Postal code
Phone
+98 13 3336 9002
Fax
Email
rsharafi@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Reza Sharafi
Position
Assistant Professor
Other areas of specialty/work
Street address
Guilan University of Medical Sciences, Namjoo Strret
City
Rasht
Postal code
Phone
+98 13 3336 9002
Fax
Email
rsharafi@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Reza Sharafi
Position
Assistant Professor
Other areas of specialty/work
Street address
Guilan University of Medical Sciences, Namjoo Strret
City
Rasht
Postal code
Phone
+98 13 3336 9002
Fax
Email
Rsharafi@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)