Oral Propranolol Versus Placebo for Early Stages of Retinopathy of Prematurity: A Randomized and Prospective Study
Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
Summary
In premature infants, propranolol (Prop) treatment might suppress continuing
neo-vascularization (NV) and decelerate the progression of retinopathy of prematurity (ROP)
towards its severe stages (III-V), thus avoiding the need of interventions (CRYO and/or LASER
photo-coagulation of the ischemic retina and preventing severe ocular sequelae. We therefore
plan to prospectively investigate the influence of prop versus placebo in VLBW infants with
ROP stage 1 (zone I), with stage 2 or higher (any zone) or with Plus disease, along with
close follow up regarding safety of prop administration and its effect on ROP.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Rambam Health Care Campus
Collaborators:
Hadassah Medical Organization Laniado Hospital Nazareth Hospital