Retinopathy of Prematurity Clinical Trial
Official title:
Safety and Efficacy of Propranolol Eye Drops in Newborns With Retinopathy of Premature (DROP-PROP)
The aim of the present study is to evaluate the safety and efficacy of propranolol eye drops
in preterm newborns with a precocious stage of retinopathy of prematurity (ROP). Preterm
newborns (gestational age 23-32 weeks) with a stage 2 ROP (zone II without plus) will
receive propranolol eye drops treatment until retinal vascularization will be completed.
Propranolol concentrations will be measured on dried blood spots during the first 3 days of
treatment and at the steady state. 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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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