Safety and Efficacy of Propranolol 0.2% Eye Drops in Treating Retinopathy of Premature: A Pilot Study (DROP-ROP-0.2%)

Meyer Children's Hospital IRCCS98 enrolled

Overview

The aim of the present study is to evaluate the safety and efficacy of propranolol 0.2% eye drops in treating preterm newborns with a precocious stage of retinopathy of prematurity (ROP). Preterm newborns (gestational age 23-32 weeks) with a stage 1 ROP will receive propranolol 0.2% eye drops treatment until retinal vascularization will be completed, but no more than 90 days. Propranolol concentrations will be measured on dried blood spots at the steady state (10th day). 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. Serial ophthalmological evaluations will be planned to monitor the efficacy of the treatment, the ROP progression and the possible complications.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Retinopathy of Prematurity

Interventions

Enrolled preterm newborns will receive propranolol as ophthalmic solution (0.2%): 3 microdrops of 6 microliters (μL) propranolol solution (= 6 μg propranolol/microdrop) will be topically applied with a calibrated pipette, in each eye, four times daily (every 6 hours). Propranolol treatment will be always associated to the conventional approach adopted by the Early Treatment for Retinopathy of Prematurity Study (ETROP) Cooperative Group.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (7)

Neonatal Intensive Care Unit, Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy

Neonatal Intensive Care Unit, A. Meyer University Childrens' Hospital

Florence, Italy

Institute of Pediatrics and Neonatology, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, University of Milan

Milan, Italy

Neonatal Intensive Care Unit, Azienda Ospedaliera San Gerardo

Monza, Italy

Piermarocchi Stefano

Padova, Italy

Neonatal Intensive Care Unit, Azienda Ospedaliera Universitaria Senese

Siena, Italy

Neonatal Intensive Care Unit, Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi

Varese, Italy