Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity
NCT ID: NCT03083431
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
276 participants
INTERVENTIONAL
2022-09-22
2026-07-31
Brief Summary
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An orally administered drug commonly used to treat hypertension, propranolol, may be effective in halting progression of ROP to severe stages, as suggested by preliminary data from small studies. As severe (threshold) ROP is an overall rare disease, the effectiveness of propranolol in combating ROP can only be assessed in a large, multicenter randomized controlled trial involving hospitals caring for extremely preterm infants of diverse origin.
Detailed Description
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Orally administered propranolol, a commonly used drug to treat hypertension, may be effective in halting progression of ROP to severe stages, as suggested by preliminary data from small studies. Propranolol has been used for decades not only in adult patients but also in newborn infants with heart diseases. Moreover, it has been licensed in 2014 for the use in newborn infants with hemangioma in the European Union, Switzerland and the United States. This multicenter randomized placebo-controlled trial aims to assess whether oral propranolol given to extremely premature infants below 28 weeks gestational age reduces the rates of threshold ROP.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Propranolol
Oral propranolol (1.6 mg propranolol-HCl/kg/d in 3-4 divided dosages) given for a maximum of 10 weeks (depending on postmenstrual gestational age at birth)
Propranolol
Oral propranolol (1.6 mg propranolol-hydrochloride/kg/d in 4 divided dosages)
Placebo
Placebo (same duration as oral propranolol solution)
Placebo
Oral solution containing the same excipients as propranolol solution
Interventions
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Propranolol
Oral propranolol (1.6 mg propranolol-hydrochloride/kg/d in 4 divided dosages)
Placebo
Oral solution containing the same excipients as propranolol solution
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
5 Weeks
15 Weeks
ALL
No
Sponsors
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Ankara University
OTHER
University Hospital Tuebingen
OTHER
University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Dirk Bassler, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
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University Hospital Tübingen
Tübingen, Baden-Wurttemberg, Germany
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland
Ankara University School of Medicine Children's Hospital
Ankara, Ankara, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Axel R Franz, Prof.
Role: primary
Christoph M Rüegger
Role: primary
Claudia Knoepfli
Role: backup
Christoph Rüegger
Role: backup
David Glauser
Role: backup
Ömer Erdeve, Prof.
Role: primary
References
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Buhrer C, Bassler D. Oral Propranolol: A New Treatment for Infants with Retinopathy of Prematurity? Neonatology. 2015;108(1):49-52. doi: 10.1159/000381659. Epub 2015 May 9.
Buhrer C, Erdeve O, Bassler D, Bar-Oz B. Oral propranolol for prevention of threshold retinopathy of prematurity (ROPROP): protocol of a randomised controlled trial. BMJ Open. 2018 Jul 6;8(7):e021749. doi: 10.1136/bmjopen-2018-021749.
Other Identifiers
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32ER30_173677
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2017-002124-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RoProp
Identifier Type: -
Identifier Source: org_study_id