Status:
COMPLETED
Oral Propranolol Versus Placebo for Early Stages of Retinopathy of Prematurity: A Randomized and Prospective Study
Lead Sponsor:
Rambam Health Care Campus
Collaborating Sponsors:
Hadassah Medical Organization
Laniado Hospital
Conditions:
Retinopathy of Prematurity
Eligibility:
All Genders
4-14 years
Phase:
PHASE1
PHASE2
Brief 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-...
Detailed Description
Retinopathy of prematurity (ROP) affects the retinal microvasculature, mostly of very-low-birth-weight (VLBW: \< 1500g) premature infants, and is a significant complication of extreme prematurity lead...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01238471
Start Date
May 1 2010
End Date
July 1 2012
Last Update
June 26 2014
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Rambam Health Care Campus
Haifa, Israel, 31096
2
Hadassah Medical Organization
Jerusalem, Israel
3
Nazareth Hospital
Nazareth, Israel
4
Laniado Hospital
Netanya, Israel