Oral Propranolol for prevention of threshold retinopathy of prematurity

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

ROP stage 3 at time of inclusion (endpoint already reached)

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

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)

Concurrent treatment with insulin (risk of hypoglycemia)

Severe liver dysfunction (GPT > 900 U/l)

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 participation in the study leads to exceptional medical or organizational problems for the patient

Lack of willingness to storage and disclosure of pseudonymous disease data in the context of the clinical trial

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival without threshold ROP (stage 3 or more severe ROP(including aggressive posterior ROP))		Survival without threshold ROP (stage 3 or more severe ROP(including aggressive posterior ROP))

Secondary Outcome Measures

Name	Time	Method
Survival without ROP treated with ablative laser surgery or intravitreal VEGF antagonists		Survival without ROP treated with ablative laser surgery or intravitreal VEGF antagonists

Trial Locations

Locations (8): Universitaet Muenster
🇩🇪
Muenster, Germany
Charite Universitaetsmedizin Berlin KöR
🇩🇪
Berlin, Germany
Vestische Caritas-Kliniken GmbH
🇩🇪
Datteln, Germany
Universitaet Leipzig
🇩🇪
Leipzig, Germany
Universitaetsklinikum Heidelberg AöR
🇩🇪
Heidelberg, Germany
Universitaetsklinikum Tuebingen AöR
🇩🇪
Tuebingen, Germany
Medizinische Hochschule Hannover
🇩🇪
Hanover, Germany
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
🇩🇪
Dresden, Germany
Universitaet Muenster
🇩🇪Muenster, Germany
Jenny Potratz
Site contact
+492518355555
info@ukmuenster.de

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