CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
propranolol +1 moredrug
Likely dose
propranolol 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01238471
NCT01238471Phase 2Completed
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Oral Propranolol Versus Placebo for Early Stages of Retinopathy of Prematurity (ROP): A Pilot, Randomized and Prospective Study.

Rambam Health Care Campus·interventional·Posted Nov 10, 2010·Updated Jun 26, 2014

In Brief

A Phase 2 clinical trial evaluating propranolol and sucrose 5% for Retinopathy of Prematurity. Completed, enrolled 20 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRetinopathy of Prematurity
CountriesIsrael
CollaboratorsHadassah Medical Organization, Laniado Hospital, Nazareth Hospital

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2010
Enrollment StartMay 1, 2010
Primary CompletionMay 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 15.6 years ago

Interventions

propranololdrug

2 mg per kg per day divided in 3 doses for 2-4 weeks

sucrose 5%drug

2 ml per Kg per day divided in 3 doses for 2-4 weeks