Overview

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:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Rambam Health Care Campus
Collaborators:
Hadassah Medical Organization
Laniado Hospital
Nazareth Hospital
Treatments:
Propranolol
Criteria
Inclusion Criteria:

Evidence for ROP that might progress and that includes any one of the following:

- Stage 1 (zone I)

- Stage 2 or higher (zones I, II or III), or Plus disease. The classification of ROP is
according to International Classification of Retinopathy of Prematurity (ICROP) 2005
(40) (Appendix I, with scheme of retina showing zones and clock hours).Zone III ROP is
not included since it will always regress spontaneously.

Exclusion Criteria:

- The presence of one or more of the following conditions at enrollment in the study:

- More than 10 episodes of bradycardia of prematurity/day (HR< 90 bpm) [

- Atrio-ventricular (A-V) block [2nd or 3rd degree]

- Significant congenital heart anomaly [not including patent ductus arteriosus, patent
foramen ovale or small ventricular septal defect]

- Heart failure

- Hypotension (mean blood pressure <45 mmHg)

- Hypoglycemia (<50mg/dL)

- Platelet count <100000/mm3