Using oral propranolol to prevent severe eye disease in premature infants
Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity
This study is testing if giving oral propranolol to extremely premature infants can help prevent severe eye disease that could lead to blindness.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 276 (estimated) |
| Ages | 5 Weeks to 15 Weeks |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 3 sites (Tübingen, Baden-Wurttemberg and 2 other locations) |
| Trial ID | NCT03083431 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of oral propranolol in preventing threshold retinopathy of prematurity (ROP) in extremely premature infants born before 28 weeks of gestation. The study involves a multicenter randomized controlled design, where infants will receive either propranolol or a placebo. The aim is to determine if propranolol can reduce the incidence of severe ROP, which can lead to blindness, compared to standard treatments that involve more invasive procedures. The trial will include infants with early stages of ROP and will assess outcomes over a defined period.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born before 28 weeks of gestation with a birth weight below 1250 grams and evidence of early-stage ROP.
Not a fit: Patients with advanced ROP requiring intervention or those with certain congenital conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive and more cost-effective option for preventing severe vision loss in premature infants.
How similar studies have performed: Preliminary data from small studies suggest that propranolol may be effective, but this trial represents a larger, more rigorous assessment of its efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Preterm infant born before 28 week's gestation * Birth weight below 1250 g * At least 5 weeks of age (at randomisation) * PMA 310/7 - 36 6/7 weeks * Ophthalmoscopic evidence of incipient 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 Exclusion Criteria: * ROP stage ≥ 3, AP-ROP or suspected AP-ROP, or any other ROP requiring an intervention (study endpoint already reached). * Conditions that indicate open label propranolol such as: thyrotoxicosis, arterial hypertension or certain heart diseases (such as tetralogy of Fallot, paroxysmal supraventricular tachycardia, or long QT syndrome) etc. * Major congenital malformations or known chromosomal anomalies * Colobomas and other eye malformations * PHACE syndrome (posterior fossa anomalies, large infantile hemangiomas of the face, neck, and/or scalp, arterial lesions, cardiac abnormalities/coarctation of the aorta, eye anomalies) (risk of cerebrovascular complications) * Very large hemangioma (risk of hyperkalemia), as judged by the attending physician * Medication of the infant with rifampicin or phenobarbitone (enhanced metabolic clearance) * Chronic kidney impairment (serum creatinine \> 1.3 mg/dl \[115 μmol/L\]) * Severe liver dysfunction (ALT (GPT) \> 900 U/L) * Known hypersensitivity to propranolol or any of the excipients (see 6.3.1.) * Prinzmetal's angina, Raynaud's phenomenon (severe peripheral arterial circulatory disturbance), or pheochromocytoma (contraindications for propranolol in adults, not occurring in newborn infants) * Any circumstances that make the investigator believe that participation in the study leads to exceptional medical or organizational problems for the patient * Conditions that prohibit propranolol therapy such as: Atrio-ventricular block grade 2 or 3 hypertrophic cardiomyopathy, sinoatrial block, uncontrolled heart failure or cardiogenic shock, bronchial asthma * Medication of the infant or the mother if breastfeeding with clonidine, reserpine, angiotensin-converting enzyme inhibitors, angiotensin-receptor antagonists (contraindicated in preterm infants) or antiarrhythmic drugs including amiodarone, propafenone, lidocaine, digoxin/digitoxin, quinidine, verapamil, diltiazem, bepridil (pharmacodynamic interaction)
Where this trial is running
Tübingen, Baden-Wurttemberg and 2 other locations
- University Hospital Tübingen — Tübingen, Baden-Wurttemberg, Germany (Recruiting)
- University Hospital Zurich — Zurich, Canton of Zurich, Switzerland (Recruiting)
- Ankara University School of Medicine Children's Hospital — Ankara, Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Dirk Bassler, M.D. — University of Zurich
- Study coordinator: Dirk Bassler, M.D.
- Email: dirk.bassler@usz.ch
- Phone: +41 44 255 53 40
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.