Evaluating the effect of oral Propranolol in preventing of the progression of retinopathy of prematurity
Design
1. Proposal approval
2. Taking the code of ethics
3. Data collection
4. Data analysis
5. Final report
Settings and conduct
Premature neonates with GA less than 32 weeks or body weigh less than or equal to 1500 grams who are admitted to Alavi or Buali hospital NICU in Ardabil . As part of the screening protocol, these babies undergo retinal examination. In this research, infants with stage 1 or higher of retinopathy of prematurity, but without indication for treatment, will be included . They will be randomly assigned to either the intervention group or the control group.The intervention group will receive oral Propranolol at a dosage of 0.5 mg per kilogram every 8 hours until the completeion of retinal vessels or discharge. It is important to note that Propranolol may affect blood pressure, blood sugar levels, and heart rate. the control group will receive an equal amount of distilled water as a placebo. Both groups will undergo regular retinal examinations by a doctor following the protocol, and any changes observed during the process will be documented.
Participants/Inclusion and exclusion criteria
Infants who are admitted to the neonatal intensive care unit of Alavi or Buali Hospital in Ardabil, with a GA of less than 32 weeks or a birth weight below 1500 grams, who require weight gain.
and have retinopathy of prematurity stage 1 or higher during examination, which does not need any intervention.
Intervention groups
Infants who have retinopathy of prematurity at stage 1 or higher but do not require any treatment for this condition.
Main outcome variables
Retinal vascularization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230717058817N1
Registration date:2023-07-24, 1402/05/02
Registration timing:registered_while_recruiting
Last update:2023-07-24, 1402/05/02
Update count:0
Registration date
2023-07-24, 1402/05/02
Registrant information
Name
Amin Najafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3325 2827
Email address
amin.najafi.dr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of oral Propranolol in pereventing the progression of retinopathy of prematurity
Public title
Evaluating the effect of oral Propranolol in preventing the progression of retinopathy of prematurity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants , with a gestational age of less than 32 weeks or a birth weight below 1500 grams,
Exclusion criteria:
Age
From 1 month old to 6 months old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
66 qualified neonates will be assigned to two groups of 33 people by random block allocation method (blocks of four).
in this study, the block randomization method will be used so that the numbers in all groups be equal .
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Artesh Street
City
Ardabil
Province
Ardabil
Postal code
8599156189
Approval date
2022-10-15, 1401/07/23
Ethics committee reference number
IR.ARUMS.MEDICINE.REC.1401.080
Health conditions studied
1
Description of health condition studied
retinopathy of prematurity
ICD-10 code
H35.103
ICD-10 code description
Retinopathy of prematurity, unspecified, bilateral
Primary outcomes
1
Description
Retinal vascularization
Timepoint
Weekly
Method of measurement
Examination
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive oral Propranolol at a dosage of 0.5 mg per kilogram every 8 hours (24 doses) until the completion of retinal vessels or discharge. It is important to note that Propranolol may affect blood pressure, blood sugar levels, and heart rate.
Category
Treatment - Drugs
2
Description
Control group: the control group will receive an equal amount of distilled water. Both groups will undergo regular retinal examinations by a doctor following the protocol, and any changes observed during the process will be documented.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alavi hospital
Full name of responsible person
Amin Najafi
Street address
Alavi hospital
City
Ardabil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3325 2827
Email
amin.najafi.dr@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Amin Najafi
Street address
Ardabil-Ardabil University of Madical Sciences
City
Ardabil
Province
Ardabil
Postal code
56189-85991
Phone
+98 45 3352 2247
Email
amin.najafi.dr@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Amin Najafi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Artesh Street
City
Ardabil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3325 2827
Email
amin.najafi.dr@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Amin Najafi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Artesh Street
City
Ardabil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3325 2827
Email
amin.najafi.dr@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Amin Najafi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Artesh Street
City
Ardabil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3325 2827
Email
amin.najafi.dr@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD