Phase 2
N=20
Oral Propranolol Versus Placebo for Early Stages of Retinopathy of Prematurity: A Randomized and Prospective Study
Retinopathy of Prematurity
Bottom Line
View on ClinicalTrials.gov: NCT01238471 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Regression of Retinopathy of Prematurity (ROP) in Premature Infants by Propranolol Therapy — 4; 8 cases
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- propranolol (Drug); sucrose 5% (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Rambam Health Care Campus
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Regression of Retinopathy of Prematurity (ROP) in Premature Infants by Propranolol Therapy |
4; 8 | — |
| SECONDARY Safety of Propranolol Therapy in Premature Infants |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01238471). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.