Actively Recruiting
Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity
Led by University of Zurich · Updated on 2026-05-07
276
Participants Needed
3
Research Sites
379 weeks
Total Duration
On this page
Sponsors
U
University of Zurich
Lead Sponsor
A
Ankara University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm infant born before 28 week's gestation
- Birth weight below 1250 g
- At least 5 weeks of age (at randomisation)
- Postmenstrual age between 31 0/7 and 36 6/7 weeks
- Ophthalmoscopic evidence of early ROP (stage 1 or 2, with or without plus disease in any zone)
- Written informed consent by parents or legal guardian according to national requirements
You will not qualify if you...
- ROP stage 3 or higher, AP-ROP or suspected AP-ROP, or any ROP requiring intervention
- Conditions requiring open label propranolol such as thyrotoxicosis, arterial hypertension, or certain heart diseases
- Major congenital malformations or known chromosomal anomalies
- Eye malformations like colobomas
- PHACE syndrome
- Very large hemangioma as judged by the attending physician
- Medication with rifampicin or phenobarbitone
- Chronic kidney impairment (serum creatinine > 1.3 mg/dl)
- Severe liver dysfunction (ALT > 900 U/L)
- Known hypersensitivity to propranolol or its excipients
- Prinzmetal's angina, Raynaud's phenomenon, or pheochromocytoma
- Medical or organizational problems making participation unsafe
- Conditions prohibiting propranolol therapy such as AV block grade 2 or 3, hypertrophic cardiomyopathy, sinoatrial block, uncontrolled heart failure or cardiogenic shock, bronchial asthma
- Medication of infant or breastfeeding mother with contraindicated drugs including clonidine, reserpine, ACE inhibitors, angiotensin receptor antagonists, or certain antiarrhythmics
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University Hospital Tübingen
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
2
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8091
Actively Recruiting
3
Ankara University School of Medicine Children's Hospital
Ankara, Ankara, Turkey (Türkiye), 06590
Actively Recruiting
Research Team
D
Dirk Bassler, M.D.
CONTACT
C
Christoph Rüegger, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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