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

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 clinical trial is studying a drug called Placebo and a drug called Propranolol for people with retinopathy of prematurity. The study is currently recruiting participants at 3 locations.

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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Interventions

DRUGPropranolol

Oral propranolol (1.6 mg propranolol-hydrochloride/kg/d in 4 divided dosages)

DRUGPlacebo

Oral solution containing the same excipients as propranolol solution


Locations(3)

University Hospital Tübingen

Tübingen, Baden-Wurttemberg, Germany

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Ankara University School of Medicine Children's Hospital

Ankara, Ankara, Turkey (Türkiye)

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NCT03083431


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