Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity (PROP-ROP)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy of Treatment With Propranolol in Newborns With Retinopathy of Prematurity: a Pilot Study|
- The primary aim is to evaluate the safety of propranolol administration [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
- The secondary aim is to evaluate the efficacy of treatment with propranolol for reducing blindness and retinal detachment in newborns with ROP [ Time Frame: six months from the beginning of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Oral Propranolol administration is the experimental arm of this study
Dosage of 0.5mg/Kg oral, every 6 hours. The study will be discontinued immediately in the presence of serious adverse effects attributable to the pharmacological actions of propranolol (severe hypotension, bradycardia or bronchospasm).
In case such events occur in any of the 3 groups of gestational age, the study could start again with half dose (0.25mg/Kg oral, every 6 hours) after notification to the Ethics Committee.
In case of surgery or induction of anesthesia during the administration of propranolol, the drug should be discontinued at least 24 hours before surgery.
In cases of severe hypotension or bradycardia may be administered one or more of the following drugs:
No Intervention: Control
Control arm is treated following the standard treatment schedule of Early Treatment For Retinopathy Of Prematurity Cooperative Group
Retinopathy of Prematurity (ROP) is still a major cause of blindness in children in developed countries around the world, and an increasing cause of blindness in developing countries. The ablation of the retina with photocoagulation by laser or cryotherapy reduces the incidence of blindness by suppressing the neovascular phase of ROP. However, the visual outcomes after treatment are often poor. The development of ROP depends largely from vascular endothelial growth factor (VEGF). The reduction of VEGF expression in the neovascular phase might prevent destructive neovascularization in ROP.
The purpose of this study is to evaluate whether the administration of propranolol is safe and is able to reduce the incidence of blindness by suppressing the neovascular phase of ROP compared to a control group receiving conventional laser therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079715
|Neonatal Intensive Care Unit - Azienda Ospedaliero-Universitaria Meyer|
|Florence, Italy, I-50139|
|Neonatal Intensive Care Unit - Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico|
|Milan, Italy, I-20122|
|Principal Investigator:||Luca Filippi, M.D.||Azienda Ospedaliero-Universitaria A. Meyer, Firenze, Italy|