Oral Propranolol: A New Treatment for Infants with Retinopathy of Prematurity?
Christoph Bührer, Dirk Bassler
https://pubmed.ncbi.nlm.nih.gov/25968340Actively Recruiting
Phase 2
Age: 5Weeks - 15Weeks
All Genders
ID03083431
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
52 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
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.
CONDITIONS
Brief Title
Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity
Who Can Participate
Age: 5Weeks - 15Weeks
All Genders
Eligibility Criteria
You may qualify if you...
- Preterm infant born before 28 weeks gestation
- Birth weight below 1250 grams
- At least 5 weeks of age at randomization
- Postmenstrual age between 31 0/7 and 36 6/7 weeks
- Ophthalmoscopic evidence of early retinopathy of prematurity (stage 1 or 2, with or without plus disease)
- Written informed consent by parents or legal guardian according to national requirements
You will not qualify if you...
- Retinopathy of prematurity stage 3 or higher, aggressive posterior ROP, or any ROP requiring intervention
- Conditions indicating open label propranolol use such as thyrotoxicosis, arterial hypertension, or specific heart diseases
- Major congenital malformations or known chromosomal anomalies
- Eye malformations such as colobomas
- PHACE syndrome
- Very large hemangioma as judged by physician
- Infant treated 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 excipients
- Contraindications for propranolol such as Prinzmetal's angina, Raynaud's phenomenon, pheochromocytoma
- Any exceptional medical or organizational problems preventing participation
- Conditions prohibiting propranolol therapy such as advanced heart blocks, hypertrophic cardiomyopathy, uncontrolled heart failure, cardiogenic shock, bronchial asthma
- Infant or breastfeeding mother taking contraindicated medications such as clonidine, reserpine, ACE inhibitors, angiotensin receptor antagonists, or certain antiarrhythmic drugs
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 10 weeks
Participants receive oral propranolol or placebo for prevention of threshold retinopathy of prematurity.
Daily dosing with regular monitoring visits
Follow-up
Duration - Up to approximately 12 weeks after treatment
Participants are followed for safety and ophthalmological outcomes until 48 weeks postmenstrual age.
Visits until 48 weeks postmenstrual age
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
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Research Team
D
Dirk Bassler, M.D.
C
Christoph Rüegger, M.D.
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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Published Research Related To This Trial
Oral propranolol for prevention of threshold retinopathy of prematurity (ROPROP): protocol of a randomised controlled trial.
Christoph Bührer, Ömer Erdeve, Dirk Bassler...
https://pubmed.ncbi.nlm.nih.gov/29982217