Safety and Efficacy of Propranolol 0.2% Eye Drops in Treating Retinopathy of Premature: A Pilot Study (DROP-ROP-0.2%)
Retinopathy of Prematurity
About this trial
This is an interventional treatment trial for Retinopathy of Prematurity focused on measuring Retinopathy of prematurity, Propranolol, Newborn, Eye Drops, Retinal angiogenesis, Retinal neovascularization
Eligibility Criteria
Inclusion Criteria:
- Preterm newborns (gestational age 23-32 weeks) with stage 1 ROP
- A signed parental informed consent
Exclusion Criteria:
- Newborns with heart failure
- Newborns with recurrent bradycardia (heart rate < 90 beat per minute)
- Newborns with second or third degree atrioventricular block
- Newborns with congenital cardiovascular anomalies, except for persistent ductus arteriosus, patent foramen ovale and small ventricular septal defects
- Newborns with hypotension
- Newborns with renal failure
- Newborns with actual cerebral haemorrhage
- Newborns with other diseases which contraindicate the use of beta-adrenoreceptor blockers.
- Newborns with a more severe stage of ROP than stage 1
Sites / Locations
- Neonatal Intensive Care Unit, Azienda Ospedaliera Spedali Civili di Brescia
- Neonatal Intensive Care Unit, A. Meyer University Childrens' Hospital
- Institute of Pediatrics and Neonatology, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, University of Milan
- Neonatal Intensive Care Unit, Azienda Ospedaliera San Gerardo
- Piermarocchi Stefano
- Neonatal Intensive Care Unit, Azienda Ospedaliera Universitaria Senese
- Neonatal Intensive Care Unit, Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
Arms of the Study
Arm 1
Experimental
Propranolol 0.2% eye drops
Enrolled preterm newborns will receive propranolol as ophthalmic solution (0.2%). The treatment will be started as soon as the diagnosis of stage 1 ROP is made and will be continue until the development of retinal vascularization is completed, but no more than 90 days. Cardiovascular and respiratory parameters will be continuously monitored. Blood samplings checking metabolic, renal and liver functions will be performed periodically, as well as cardiac function, in order to verify the treatment safety. Propranolol concentrations will be measured on dried blood spots at the steady state (10th day). Serial ophthalmological evaluations will be planned to monitor the efficacy of the treatment, the ROP progression and the possible complications.