Evaluation of the Oral Propranolol Effect on Retinopathy of Prematurity: Randomized Clinical Trial

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Akram Mirjalili Masoud Reza Manaviat Mahmood Noori-Shadkam


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.

Keywords: Retinopathy of Prematurity, Propranolol, Infant, NICU

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How to Cite
Mirjalili, A., Manaviat, M. R., & Noori-Shadkam, M. (2019, August 17). Evaluation of the Oral Propranolol Effect on Retinopathy of Prematurity: Randomized Clinical Trial. World Journal of Peri and Neonatology, 37-43. Retrieved from http://wjpn.journalonweb.ir/index.php/wjpn/article/view/22
Original Articles


1. Léauté-Labrèze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taïeb A. Propranolol for severe hemangiomas of infancy. N Engl J Med 2008; 358(24): 2649-51.
2. Léauté‐Labrèze C, Dumas de la Roque E, Nacka F, Abouelfath A, Grenier N, Rebola M, et al. Double‐blind randomized pilot trial evaluating the efficacy of oral propranolol on infantile haemangiomas in infants< 4 months of age. Br J Dermatol 2013; 169(1): 181-3.
3. Lou Y, Peng Wj, Cao Y, Cao Ds, Xie J, Li HH. The effectiveness of propranolol in treating infantile haemangiomas: a meta‐analysis including 35 studies. Br J Clin Pharmacol. 2014; 78(1): 44-57.
4. Gilbert C. Retinopathy of prematurity: a global perspective of the epidemics, population of babies at risk and implications for control. Early Hum Dev 2008; 84(2): 77-82.
5. Good WV, Hardy RJ, Dobson V, Palmer EA, Phelps DL, Quintos M, et al. The incidence and course of retinopathy of prematurity: findings from the early treatment for retinopathy of prematurity study. Pediatrics 2005; 116(1): 15-23.
6. Marcdante K, Kliegman RM. Nelson essentials of pediatrics. 7th ed. Philadelphia, PA: Elsevier Health Sciences; 2014.
7. Penn JS, Madan A, Caldwell RB, Bartoli M, Caldwell RW, Hartnett ME. Vascular endothelial growth factor in eye disease. Prog Retin Eye Res 2008; 27(4): 331-71.
8. Saunders RA, Donahue ML, Christmann LM, Pakalnis AV, Tung B, Hardy RJ, et al. Racial variation in retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol 1997; 115(5): 604-8.
9. Baker JG. The selectivity of β-adrenoceptor antagonists at the human β1, β2 and β3 adrenoceptors. Br J Pharmacol 2005; 144(3): 317-22.
10. Smith LE, Wesolowski E, McLellan A, Kostyk SK, D'Amato R, Sullivan R, et al. Oxygen-induced retinopathy in the mouse. Invest Ophthalmol Vis Sci 1994; 35(1): 101-11.
11. Filippi L, Cavallaro G, Berti E, Padrini L, Araimo G, Regiroli G, et al. Study protocol: safety and efficacy of propranolol 0.2% eye drops in newborns with a precocious stage of retinopathy of prematurity (DROP-ROP-0.2%): a multicenter, open-label, single arm, phase II trial. BMC Pediatr 2017; 17(1): 165.
12. Filippi L, Cavallaro G, Bagnoli P, Dal Monte M, Fiorini P, Donzelli G, et al. Oral propranolol for retinopathy of prematurity: risks, safety concerns, and perspectives. J Pediatr 2013; 163(6): 1570-1577.e6.
13. Bancalari A, Schade R, Munoz T, Lazcano C, Parada R, Pena R. Oral propranolol in early stages of retinopathy of prematurity. J Perinat Med 2016; 44(5): 499-503.
14. Korkmaz L, Bastug O, Ozdemir A, Korkut S, Karaca C, Akin MA, et al. The efficacy of propranolol in retinopathy of prematurity and its correlation with the platelet mass index. Curr Eye Res 2017; 42(1): 88-97.
15. Ozturk MA, Korkmaz L. The efficacy of propranolol in very preterm infants at the risk of retinopathy of prematurity: Which
newborn and when? Int Ophthalmol 2018.
[Epub ahead of print].
16. Makhoul IR, Peleg O, Miller B, Bar-Oz B, Kochavi O, Mechoulam H, et al. Oral propranolol versus placebo for retinopathy of prematurity: a pilot, randomised, double-blind prospective study. Arch Dis Child 2013; 98(7):
17. Buhrer C, Erdeve O, Bassler D, Bar-Oz B. Oral propranolol for prevention of threshold retinopathy of prematurity (ROPROP): protocol of a randomised controlled trial. BMJ Open 2018; 8(7): e021749.