Oral Propranolol to Prevent Severe Retinopathy of Prematurity in Extremely Premature Infants

What this Trial Is About

Researchers are studying extremely premature infants who are at risk of developing retinopathy of prematurity ROP, a serious eye condition that can lead to blindness. This trial evaluates whether oral propranolol, a drug commonly used for hypertension, can prevent severe stages of ROP. The study is a large, multicenter, randomized controlled trial aiming to assess the effect of propranolol on reducing the rates of threshold ROP in infants born before 28 weeks gestation. Participants receive either oral propranolol at a dose of 1.6 mg per kg per day divided into 3 to 4 doses for up to 10 weeks, or a placebo solution matching the propranolol treatment duration. The study includes a placebo-controlled group and follows a quadruple masking design to ensure unbiased results. Treatments are given depending on postmenstrual age at birth, with the goal of halting ROP progression. During the trial, infants are monitored closely with eye examinations to detect any progression of ROP or adverse outcomes. The primary outcome measured is survival without adverse ophthalmological effects, such as severe ROP or the need for treatment, assessed at 48 weeks postmenstrual age. Secondary outcomes include time to adverse events, survival rates, recurrence of ROP, and need for additional therapies. Safety and survival are tracked until discharge and 48 weeks postmenstrual age, with follow-up visits extending up to 70 weeks postmenstrual age for certain measures.

Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity