Safety and efficacy of treatment with propranolol in newborns suffering from rethinopathy of the preterm: a pilot study

INTERVENTION: Product Name: Propranolol Pharmaceutical Form: Syrup INN or Proposed INN: Propranolol Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2‐ CONDITION: Retinopathy of the preterm ; MedDRA version: 9.1 Level: HLGT Classification code 10047060 PRIMARY OUTCOME: Main Objective: To evaluate, through a prospective randomized study, the efficacy of oral propranolol (combined with standard treatment)in order to reduce the progression of ROP Primary end point(s): Number of newborns with ROP pre‐threshold, threshold and Stadium IV Secondary Objective: To evaluate the safety of this treatment INCLUSION CRITERIA: Newborns with gestational age 23‐32 weeks with ROP Stadium 2 Zone II‐III without plus Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range