Safety and Efficacy of Propranolol Eye Drops in Treating Retinopathy of Premature (DROP-PROP)
Retinopathy of Prematurity
About this trial
This is an interventional treatment trial for Retinopathy of Prematurity focused on measuring Retinopathy of prematurity, Propranolol, Eye drops, Newborns, Retinal angiogenesis, Retinal neovascularization
Eligibility Criteria
Inclusion Criteria:
- Preterm newborns (gestational age 23-32 weeks) with stage 2 ROP, zone II without plus.
- A signed parental informed consent.
Exclusion Criteria:
- Newborns with heart failure;
- Newborns with congenital cardiovascular anomalies, except for persistent ductus arteriosus, patent foramen ovale and small ventricular septal defects;
- Newborns with recurrent bradycardia (heart rate < 90 beat per minute);
- Newborns with second or third degree atrioventricular block;
- Newborns with hypotension;
- Newborns with renal failure;
- Newborns with actual cerebral haemorrhage;
- Newborns with other diseases which contraindicate the use of beta-adrenoreceptor blockers.
Sites / Locations
- 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
Arms of the Study
Arm 1
Experimental
Propranolol eye drops
All the enrolled preterm newborns will receive propranolol as ophthalmic solution (0,1%): 3 microdrops of 6 microliters (μL) propranolol solution (= 6 μg propranolol/microdrop) will be topically applied with a calibrated pipette, in each eye, three times daily (every 8 hours).The treatment will continue until the complete development of retinal vascularization, but no more than 60 days. The propranolol treatment will be always associated to the conventional approach adopted by the Early Treatment for Retinopathy of Prematurity Study (ETROP Cooperative Group.