Study protocol: Safety and efficacy of propranolol in newborns with Retinopathy of Prematurity (PROP-ROP): ISRCTN18523491

Luca Filippi, Giacomo Cavallaro, Patrizio Fiorini, Marta Daniotti, Valentina Benedetti, Gloria Cristofori, Gabriella Araimo, Luca Ramenghi, Agostino L. Torre, Pina Fortunato, Liliana Pollazzi, Giancarlo L. Marca, Sabrina Malvagia, Paola Bagnoli, Chiara Ristori, Massimo D. Monte, Anna R. Bilia, Benedetta Isacchi, Sandra Furlanetto, Francesca TinelliGiovanni Cioni, Gianpaolo Donzelli, Silvia Osnaghi, Fabio Mosca

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Abstract

Background: Despite new therapeutic approaches have improved the prognosis of newborns with retinopathy of prematurity (ROP), an unfavourable structural and functional outcome still remains high. There is high pressure to develop new drugs to prevent and treat ROP. There is increasing enthusiasm for anti-VEGF drugs, but angiogenic inhibitors selective for abnormal blood vessels would be considered as an optimal treatment.In an animal experimental model of proliferative retinopathy, we have recently demonstrated that the pharmacological blockade of beta-adrenoreceptors improves retinal neovascularization and blood retinal barrier breakdown consequent to hypoxia. The purpose of this study is to evaluate the propranolol administration in preterm newborns suffering from a precocious phase of ROP in terms of safety and efficacy in counteracting the progression of retinopathy.Methods/Design: Preterm newborns (gestational age at birth lower than 32 weeks) with stage 2 ROP (zone II-III without plus) will be randomized, according to their gestational age, to receive propranolol added to standard treatment (treatment adopted by the ETROP Cooperative Group) or standard treatment alone. Propranolol will be administered until retinal vascularization will be completely developed, but not more than 90 days. Forty-four participants will be recruited into the study. To evaluate the safety of propranolol administration, cardiac and respiratory parameters will be continuously monitored. Blood samplings will be performed to check renal, liver and metabolic balance. To evaluate the efficacy of propranolol, the progression of the disease, the number of laser treatments or vitrectomies, the incidence of retinal detachment or blindness, will be evaluated by serial ophthalmologic examinations. Visual function will be evaluated by means of behavioural standardized tests.Discussion: This pilot study is the first research that explores the possible therapeutic role of beta blockers in ROP. The objective of this research is highly ambitious: to find a treatment simple, inexpensive, well tolerated and with few adverse effects, able to counteract one of the major complications of the prematurity. Any favourable results of this research could open new perspectives and original scenarios about the treatment or the prevention of this and other proliferative retinopathies.Trial Registration: Current Controlled Trials ISRCTN18523491; ClinicalTrials.gov Identifier NCT01079715; EudraCT Number 2010-018737-21.

Original languageEnglish
Article number83
JournalBMC Pediatrics
Volume10
DOIs
Publication statusPublished - Nov 18 2010

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ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Filippi, L., Cavallaro, G., Fiorini, P., Daniotti, M., Benedetti, V., Cristofori, G., Araimo, G., Ramenghi, L., Torre, A. L., Fortunato, P., Pollazzi, L., Marca, G. L., Malvagia, S., Bagnoli, P., Ristori, C., Monte, M. D., Bilia, A. R., Isacchi, B., Furlanetto, S., ... Mosca, F. (2010). Study protocol: Safety and efficacy of propranolol in newborns with Retinopathy of Prematurity (PROP-ROP): ISRCTN18523491. BMC Pediatrics, 10, [83]. https://doi.org/10.1186/1471-2431-10-83