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IRCT20101018004961N12 IRCT 2021-07-17 Kermanshah University of Medical Sciences Investigating the efficacy of oral propranolol in prevention of severe Retinopathy of Prematurity Investigating the efficacy of oral propranolol in prevention of severe Retinopathy of Prematurity : A Randomized Clinical Trial 2021-07-04 anticipated 50 Complete https://irct.ir/trial/57268 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In the present study, the random allocation method using the variable block method will be used.Volunteers participating in the study are assigned to the propranolol treatment group and the control group using block randomization with 4 and 6 blocks. The main tool in the design is a questionnaire that has been prepared by the project manager based on the main objectives and important and basic variables of the design The collected data will be entered into SPSS statistical software version 20 and will be statistically analyzed. A random sequence generated by the computer and a design methodologist colleague will be used to assign intervention and placebo to participants, Blinding description: newborns and their parents, in both groups, will not know about their treatment(According to placebo consumption in the control group). The outcome assessor (retinal subspecialty) is also unaware of the allocation of infants to propranolol and control treatment groups(The study is double-blind).Determining this blinding is the responsibility of the neonatologist who specializes in the project (the only person who is aware of the grouping). 3 Retinopathy of prematurity. Intervention group: In the study group, after diagnosis of grade 1 or 2 retinopathy of prematurity in ophtalmic examination, oral propranolol (Hakim Pharmaceutical Company - Made in Iran) is started at a dose of 0.5 mg / kg every 8 hours and the drug is continued until the retinal vascularity are complete (for at least 3 months) or the need for laser therapy .. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Pourang Mohammadi
Imam Reza Hospital, Parastar Boulevard, Kermanshah
Kermanshah Iran (Islamic Republic of) 6742775333 0098 83 34276300-20 pourangmohammadi@yahoo.com Kermanshah University of Medical Sciences scientific Homa Babaei
Imam Reza Hospital, Parastar Boulevard , Kermanshah
Kermanshah Iran (Islamic Republic of) 6742775333 0098 83 34276300-20 Homa_babaei@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) newborns with gestational age ≤34 weeks or birth weight ≤2000 g with retinopathy of prematurity stage I or II 28 days 120 days Both Infants with congenital anomalies heart diseases except PDA recurrent bradycardia eye malformations acute renal failure IVH grade II and III, acute sepsis H35.1 Retinopathy of prematurity Prevention Intervention group: In the study group, after diagnosis of grade 1 or 2 retinopathy of prematurity in ophtalmic examination, oral propranolol (Hakim Pharmaceutical Company - Made in Iran) is started at a dose of 0.5 mg / kg every 8 hours and the drug is continued until the retinal vascularity are complete (for at least 3 months) or the need for laser therapy . Stage of retinopathy. Timepoint: Day 28 after birth and then every 1 to 2 weeks until the retinal vascular are complete. Method of measurement: Ophthalmoscopic eye examination. Kermanshah University of Medical Sciences Approved 2021-06-29 Research Ethics Committtees Of Kermanshah University Of Medical Sciences Deputy of Research and Technology, Building No. 2, Shahid Beheshti Blvd., Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)