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Oral Propranolol for prevention of threshold retinopathy of prematurity
EU CTIS ID: 2024-511338-10-01
What this study is testing
To assess the safety and efficacy of orally administered propranolol to reduce the risk of threshold retinopathy of prematurity in extremely preterm infants
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Preterm infant born before 28 weeks gestation
- Birth weight below 1250 g
- Alive at 5 weeks of age
- Postmenstrual age 31 0/7 – 36 6/7 weeks
- Ophthalmoscopic evidence of incipient ROP (stage 1 or 2, with or without plus disease)
- Written informed consent by parents or legal guardian, including saving and propagation of pseudonymous medical data for study purposes, according to national requirements
You likely can't join if
- ROP stage ≥ 3, AP-ROP or suspected AP-ROP, or any other ROP requiring an intervention (study endpoint already reached)
- Chronic kidney impairment (creatinine > 1.3 mg/dl [100 μM])
- Persistent hypoglycemia (blood glucose < 36 mg/dl [2.0 mM] in 3 consecutive samples immediately preceding enrollment)
- Thyrotoxicosis, arterial hypertension or congenital heart diseases requiring open-label propranolol treatment (such as tetralogy of Fallot, paroxysmal supraventricular tachycardia, or long QT syndrome)
- Persistent hyperkalemia (venous serum potassium > 5.9 mM in 3 consecutive samples immediately preceding enrollment)
- Persistent neutropenia (absolute neutrophil counts <1,000/μL in 3 consecutive samples immediately preceding enrollment)
See the full eligibility criteria
Who can join
- Preterm infant born before 28 weeks gestation
- Birth weight below 1250 g
- Alive at 5 weeks of age
- Postmenstrual age 31 0/7 – 36 6/7 weeks
- Ophthalmoscopic evidence of incipient ROP (stage 1 or 2, with or without plus disease)
- Written informed consent by parents or legal guardian, including saving and propagation of pseudonymous medical data for study purposes, according to national requirements
What rules you out
- ROP stage ≥ 3, AP-ROP or suspected AP-ROP, or any other ROP requiring an intervention (study endpoint already reached)
- Chronic kidney impairment (creatinine > 1.3 mg/dl [100 μM])
- Persistent hypoglycemia (blood glucose < 36 mg/dl [2.0 mM] in 3 consecutive samples immediately preceding enrollment)
- Thyrotoxicosis, arterial hypertension or congenital heart diseases requiring open-label propranolol treatment (such as tetralogy of Fallot, paroxysmal supraventricular tachycardia, or long QT syndrome)
- Persistent hyperkalemia (venous serum potassium > 5.9 mM in 3 consecutive samples immediately preceding enrollment)
- Persistent neutropenia (absolute neutrophil counts <1,000/μL in 3 consecutive samples immediately preceding enrollment)
- Known hypersensitivity to propranolol or any of the excipients
- Prinzmetal's angina, Raynaud's phenomenon (severe peripheral arterial circulatory disturbance), or pheochromocytoma (contraindications for propranolol in adults, not occurring in newborn infants)
- Participation in another pharmacological interventional clinical trial
- Any circumstances that make the investigator believe that in the infant’s own interest, he/she should no longer receive the study medication
- Lack of willingness to storage and disclosure of pseudonymous disease data in the context of the clinical trial
- 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)
- Atrio-ventricular block grade 2 or 3 (contraindication for propranolol)
- Sinuatrial block (contraindication for propranolol)
- Uncontrolled heart failure or cardiogenic shock (contraindication for propranolol)
- Acute severe infection (inclusion may be postponed until infection has resolved)
- Bronchial asthma
- Major congenital malformations or known chromosomal anomalies
- Colobomas and other eye malformations
- > 7 days after first ROP diagnosis (day 1 = first ROP diagnosis)
- Previous or current conditions that indicated/indicate beta-blocker therapy, open label propranolol such as: thyrotoxicosis, arterial hypertension or certain heart diseases (such as tetralogy of Fallot, paroxysmal supraventricular tachycardia long QT syndrome, or hypertrophic cardiomyopathy)
- Very large hemangioma (risk of hyperkalemia), as judged by the attending physician
- Heart rate consistently (>1 h) < 100/min
- Noninvasive mean arterial pressure consistently (>1 h) <40 mmHg
- Medication of the infant or the mother if breastfeeding with clonidine, reserpine, angiotensin-converting enzyme inhibitors, angiotensinreceptor antagonists, or antiarrhythmic drugs including amiodarone, propafenone, lidocaine, digoxin/digitoxin, quinidine, verapamil, diltiazem, or bepridil (pharmacodynamic interaction)
- Medication of the infant with rifampicin or phenobarbitone (enhanced metabolic clearance), clonidine, antiarrhythmic drugs (amiodarone, propafenone, lidocaine, digoxin/digitoxin, quinidine), verapamil, diltiazem, bepridil), antihypertensive agents (reserpine, angiotensinconverting enzyme inhibitors, angiotensin-receptor antagonists, (pharmacodynamic drug interaction)
- Concurrent treatment with insulin (risk of hypoglycemia)
- Severe liver dysfunction (GPT > 900 U/l)
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.