RecruitingPhase 2NCT03083431

Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity

Sponsor

University of Zurich

Enrollment

276 participants

Start Date

Sep 22, 2022

Study Type

INTERVENTIONAL

Conditions

Retinopathy of Prematurity

Summary

Extremely premature infants are at risk of developing a potentially blinding eye disease, called retinopathy of prematurity (ROP). Currently available treatment, consisting of laser surgery or injection of drugs into the eye balls, may prevent most but not all cases of permanent ROP-mediated blindness. Both types of treatment are associated with significant costs and side effects. An orally administered drug commonly used to treat hypertension, propranolol, may be effective in halting progression of ROP to severe stages, as suggested by preliminary data from small studies. As severe (threshold) ROP is an overall rare disease, the effectiveness of propranolol in combating ROP can only be assessed in a large, multicenter randomized controlled trial involving hospitals caring for extremely preterm infants of diverse origin.

Eligibility

Min Age: 5 WeeksMax Age: 15 Weeks

Plain Language Summary

Simplified for easier understanding

This study is testing whether oral propranolol — a medication commonly used for heart conditions — can prevent severe retinopathy of prematurity (ROP) from developing in premature babies. ROP is an eye condition in very premature infants that can lead to vision loss if not treated. You may be eligible if... - Your baby was born before 28 weeks of gestation - Your baby weighed less than 1,250 grams at birth - Your baby is at least 5 weeks old and between 31 and 36 weeks of corrected gestational age - Your baby's eye exam shows early-stage ROP (stage 1 or 2) not yet requiring intervention - You as a parent or guardian have given written informed consent You may NOT be eligible if... - Your baby already has stage 3 or aggressive ROP requiring immediate treatment - Your baby has major birth defects or chromosomal abnormalities - Your baby has certain heart conditions such as AV block, hypertrophic cardiomyopathy, or uncontrolled heart failure - Your baby has severe liver dysfunction or significant kidney impairment - Your baby is on medications that interact with propranolol - Your baby has PHACE syndrome Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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