Efficacy of Oral Propranolol in Prevention of Severe Retinopathy of Prematurity: A Randomized Clinical Trial Study

Background: Retinopathy of prematurity (ROP) is a disease of the retinal vessels in premature newborns and can lead to a wide range of vision disorders from minor correctable visual acuity defects to retinal detachment. The present study aimed to determine the efficacy of oral propranolol in the prevention of severe ROP.Methods: This randomized clinical trial study was conducted on ۵۰ preterm newborns with retinopathy stage I or II without plus disease hospitalized at Imam Reza Hospital of Kermanshah city, Kermanshah, Iran. The samples were randomized into two groups (n=۲۵ each). The intervention group received ۰.۵ mg/kg propranolol orally every ۸ hours and was continued until retinal vascularization completion or the need for treatment by laser therapy or Avastin injection. In contrast, the control group received only routine care without receiving propranolol. Afterward, the two groups were compared in terms of progression to stage III and above of retinopathy, plus disease, retinal detachment, need for laser therapy or Avastin injection, and the duration of the retinal vascularization completion. Adverse events related to propranolol, such as hypoglycemia, hypotension, and bradycardia, were continuously monitored during the study. Finally, the data were entered into SPSS۲۴ software and analyzed.Results: The two groups did not differ significantly in terms of demographic variables at the beginning of the study. The means of gestational age and numbers (%) of boys were ۲۹±۱.۲۹ vs. ۲۹.۲۰±۱.۳۵ and ۱۴ (۵۶%) vs. ۱۱ (۴۴%) in the intervention and control groups, respectively. After the intervention, the duration of the completion of retinal vessels (day) was shorter in newborns receiving oral propranolol (۶۱.۰۴±۶.۱۳) than in the control group (۷۰.۰۸±۵.۷۲) (P<۰.۰۰۱). Moreover, the recovery rate from retinopathy and the incidence rate of plus disease were ۸۸% vs. ۶۸% and ۴% vs. ۱۲% in the intervention and control groups, respectively; however, this difference was not statistically significant (P>۰.۰۵). No adverse events related to propranolol were observed.Conclusion: Although the duration of the completion of retinal vascularization was shorter in newborns receiving oral propranolol, it was not effective in preventing severe ROP. Multicenter clinical trial studies with a higher sample size are recommended.

Keywords:

Efficacy , Oral propranolol , Retinopathy of prematurity