Oral Propranolol for prevention of thresholdretinopathy of prematurity

Recruitment & Eligibility

Status: Recruiting withdrawn before recruiting started

Sex: All

Target Recruitment: 0

Inclusion Criteria

• Preterm infant born before 28 weeks gestation
• Birth weight below 1250 g
• Alive at 5 weeks of age
• Postmenstrual age 310/7 – 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)
• Thyrotoxicosis, arterial hypertension or congenital heart diseases requiring open-label propranolol treatment (such as tetralogy of Fallot, paroxysmal supraventricular tachycardia,
or long QT syndrome)
• 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
• 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, angiotensin-receptor antagonists, 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)
• 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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival without threshold ROP (retinopathy of prematurity) (stage 3 or more)<br>[time frame: 48 weeks postmenstrual age]<br>Endpoint: ROP-grade; timepoint: 48 weeks corrected postmenstrual age; <br>method: ophthalmoscopy

Secondary Outcome Measures

Name	Time	Method
Survival without ROP treated with ablative laser surgery or intravitreal VEGF antagonists<br>[time frame: 48 weeks postmenstrual age]

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