Orales Propranolol zur Prävention einer höhergradigen Frühgeborenen-Retinopathie

Drug: Propranolol;Drug: Placebo

Gender: All
Maximum age: 15 Weeks
Minimum age: 5 Weeks

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 ?mol/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)