NCT01079715

Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity

Safety and Efficacy of Treatment With Propranolol in Newborns With Retinopathy of Prematurity: a Pilot Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Meyer Children's Hospital IRCCS · Academic / Other
• Sex: All
• Age: 22 Weeks – 32 Weeks
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the administration of propranolol is effective in the treatment of the retinopathy of the prematurity.

Detailed description

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.

Conditions

• Retinopathy of Prematurity

Interventions

Type	Name	Description
DRUG	Propranolol	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: * Atropine. * Isoproterenol hydrochloride (isoprenaline. * Terlipressin. * Glucagon In case of severe bronchospasm may be used salbutamol aerosol or salbutamol + ipratropium bromide. Betamethasone could be used for aerosol or systemic (intravenous or intramuscular).

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2010-03-03
• Last updated: 2012-11-27

Locations

2 sites across 1 country: Italy