Retinopathy of Prematurity
Conditions
Keywords
Retinopathy of prematurity, Propranolol, Newborn, Eye Drops, Retinal angiogenesis, Retinal neovascularization
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.
Interventions
DRUGPropranolol 0.2% eye drops
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.
Sponsors
Meyer Children's Hospital IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 2 without plus ROP | 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 |
| Number of newborns who need vitrectomy | 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 4 with total or partial retinal detachment | participants will be followed for the duration of hospital stay, an expected average of 2 months |
Countries
Italy
Outcome results
None listed