Evaluation of the Oral Propranolol Effect on Retinopathy of Prematurity: Randomized Clinical Trial
Background: Despite rapid advances in neonatal care in both industrialized and developing countries, retinopathy of prematurity (ROP) still remains the main reason of infants' blindness and visual impairment. There is some evidence that Beta-adrenergic system may be involved in infants' ROP. Considering that few studies have been done on effects of oral propranolol on prevention retinopathy pre maturity in premature infants, we designed this clinical trial to investigate the effects of oral propranolol on infants.
Methods: This study is a clinical trial in which 27 premature infants with gestational age greater than 27 weeks and afflicted with retinopathy pre maturity grade 1 and 2 hospitalized at Shahid Sadoughi hospital of Yazd city.They were randomized to receive 0.5 mg/kg/12hours oral propranolol or control. Premature infants were controlled and hospitalized at NICU and their BP, heart rate and Hyperemesis gravidarum (H.G) were monitored.
Results: Twenty-four newborns were included, 12 in the control group and 12 in the propranolol group and 3 of infants were excluded from the study (2 of propranolol group and 1 of control group) 81.34 percent of treatment group were recovered and healed compared to 66.7 percent of control group which not significantly difference.
Conclusion: Some studies about Beta Blockers' recessive effect on ROP have been done which in most recovery was the result but some serious side effects were also reported. In this study there was no positive effect on recovery of ROP but the percent of recovery was slightly higher in propranolol group compared to control group. Fortunately there were no reports of side effects this time due to usage of lower dose propranolol.
Recent studies state that propranolol cannot be used as a good alternative to other treatments but it can prevent the disease from getting worse. We can also reduce its side effects by changing the dosage.