Safety and Efficacy of Propranolol 0.2% Eye Drops in Treating Retinopathy of Premature: A Pilot Study (DROP-ROP-0.2%)
- Registration Number
- NCT02504944
- Lead Sponsor
- Azienda Ospedaliero, Universitaria Meyer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
- Preterm newborns (gestational age 23-32 weeks) with stage 1 ROP
- A signed parental informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Propranolol 0.2% eye drops 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.
- Primary Outcome Measures
Name Time Method Incidence rate of progression from stage 1 ROP to zone II stage 2 ROP with plus participants will be followed for the duration of hospital stay, an expected average of 2 months Incidence rate of progression from stage 1 ROP to zone II stage 3 ROP with plus participants will be followed for the duration of hospital stay, an expected average of 2 months Plasma concentrations of propranolol at the steady state measured by dried blood spots 10th day of treatment
- Secondary Outcome Measures
Name Time Method Number of newborns who progress to Stage 2 without plus ROP participants will be followed for the duration of hospital stay, an expected average of 2 months Number of newborns who progress to Stage 3 without plus ROP participants will be followed for the duration of hospital stay, an expected average of 2 months Number of newborns who progress to Stage 5 ROP with total or partial retinal detachment participants will be followed for the duration of hospital stay, an expected average of 2 months Number of newborns who progress to Stage 4 with total or partial retinal detachment participants will be followed for the duration of hospital stay, an expected average of 2 months Number of newborns who need vitrectomy participants will be followed for the duration of hospital stay, an expected average of 2 months Collection of adverse events due to eye drop propranolol treatment participants will be followed for the duration of hospital stay, an expected average of 2 months
Trial Locations
- Locations (7)
Neonatal Intensive Care Unit, Azienda Ospedaliera San Gerardo
🇮🇹Monza, Italy
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
Piermarocchi Stefano
🇮🇹Padova, Italy
Neonatal Intensive Care Unit, Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Italy
Neonatal Intensive Care Unit, Azienda Ospedaliera Universitaria Senese
🇮🇹Siena, Italy