Using oral propranolol to prevent severe eye disease in premature infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.