Effect of oral propranolol on clinical findings and complications in retinopathy of premature infants: a randomized controlled trial.

BACKGROUND: This study aimed to investigate the efficacy and safety of oral propranolol in reducing the progression of retinopathy of prematurity (ROP) and its associated complications. MATERIALS AND METHODS: This randomized controlled trial was conducted on preterm infants with ROP. Participants were randomly assigned to either a propranolol group receiving oral propranolol (0.5 mg/kg every 8 hours) or a control group receiving distilled water. The primary outcome was the duration of complete retinal vascularization. Secondary outcomes included ROP stage and severity, vital signs, and potential complications (hypoglycemia, bradycardia, and hypotension). RESULTS: A total of 61 infants (31 in the propranolol group and 30 in the control group) were included in the final analysis. There was no significant difference in the distribution of ROP stage and severity between the groups (P = 0.40). However, the duration of complete retinal vascularization was significantly shorter in the propranolol group [76.9 standard deviation (SD) = 11.06) days] compared to the control group [89.6 (SD = 9.6) days] (P < 0.001). While hypotension was more frequent in the propranolol group (45.1%) compared to the control group (26.7%), this difference was not statistically significant (P = 0.18). CONCLUSION: Oral propranolol significantly reduced the time required for retinal vascularization in infants with ROP. The treatment was well-tolerated, with no serious adverse effects such as hypoglycemia or bradycardia. Although hypotension was more common in the propranolol group, the difference was not statistically significant. These findings suggest that oral propranolol may be a safe and effective adjunct therapy for ROP.