Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity

Launched by UNIVERSITY OF ZURICH · Mar 13, 2017

Keywords

ClinConnect Summary

This clinical trial is investigating whether an oral medication called propranolol can help prevent a serious eye condition known as retinopathy of prematurity (ROP) in extremely premature infants. ROP can lead to vision problems or blindness in babies born before 28 weeks of pregnancy. While current treatments involve laser surgery or injections into the eye, these can be costly and may have side effects. Propranolol is commonly used for high blood pressure and early studies suggest it might help stop ROP from getting worse.

To participate in this trial, infants must be born before 28 weeks of gestation, weigh less than 1250 grams (about 2.75 pounds), and be at least 5 weeks old. They also need to show early signs of ROP, specifically stages 1 or 2. Parents or guardians will need to provide their consent for their child to take part. If eligible, participants will receive propranolol or a placebo (a harmless substance) and will be monitored closely throughout the study. It's important for families to know that this trial is taking place at multiple medical centers, which allows for a diverse group of infants to be studied, helping researchers understand if propranolol is an effective treatment for ROP.

Gender

ALL

Eligibility 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)