Investigating the efficacy of oral propranolol in prevention of severe Retinopathy of Prematurity : A Randomized Clinical Trial

Investigating the efficacy of oral propranolol in prevention of severe Retinopathy of Prematurity

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 50 patients. Excel software rand function is used for randomization.

In this study, preterm infants admitted to the neonatal intensive care unit of Imam Reza (AS) Hospital in Kermanshah,with gestational age≤34 weeks or have a birth weight of ≤2000 g , and their ophtalmic examination confirms the diagnosis of grade 1 or 2 retinopathy enter the study and randomly enrolled in one of two groups, both groups are evaluated and compared for improvement or progression to higher ROP degree (grade 3 or higher) and the need for invasive treatments including laser therapy and intraocular injection of Avastin, . Examinations continue until the retinal vascularity are complete or retinopathy regress.

Inclusion criteria: newborns with gestational age ≤34 weeks or birth weight ≤2000 g with retinopathy of prematurity stage I or II without plus disease. Exclusion criteria: newborns with congenital anomalies, heart diseases except PDA ,recurrent bradycardia, eye malformations, acute renal failure , IVH grade II and III, acute sepsis

In the case group, after diagnosis, oral propranolol with a dose of 0.5 mg/kg is started every 8 hours and the medication continues until Retinal vascularity completion on ophthalmic examination or the need for laser therapy. Infants in the control group receive routine care for premature infants and do not receive medication.

The rate of recovery from retinopathy of prematurity , the need for avastin injections, the need for laser treatment

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.

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).