H35.1
Conditions
Interventions
Group 1: Verum - Oral Propranolol-HCl (1.6 mg/ kg*d) given for 4-10 weeks
Group 2: Placebo - same duration as oral propranolol solution
Sponsors
Universität Zürich
Eligibility
Sex/Gender
All
Age
35 Days to 104 Days
Inclusion criteria
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
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) 1 h) 900 U/L) • Chronic kidney impairment (creatinine > 1.3 mg/dl [100 µM]) • Persistent hypoglycemia (blood glucose 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival without threshold ROP (retinopathy of prematurity) (stage 3 or more) [time frame: 48 weeks postmenstrual age] Endpoint: ROP-grade; timepoint: 48 weeks corrected postmenstrual age; method: ophthalmoscopy | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival without adverse ophthalmological outcome, defined as ROP >= 3, AP-ROP, or any ROP treatment [time frame: 48 weeks postmenstrual age] | — |
Countries
Germany, Switzerland, Turkey
Contacts
Public ContactAxel Franz
Universitätsklinikum Tübingen
Outcome results
None listed