Safety and Efficacy of Treatment With Propranolol in Newborns With Retinopathy of Prematurity: a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- The primary aim is to evaluate the safety of propranolol administration
研究概览
简要总结
The purpose of this study is to determine whether the administration of propranolol is effective in the treatment of the retinopathy of the prematurity.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 22 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants who have been screened for ROP (≤ 32 weeks gestation) who develop Stage 2 ROP in zone II without plus.
- •Informed Consent from a parent
排除标准
- •Newborns with one or more of the following conditions at the enrollment in the study:
- •Heart failure.
- •Recurrent episodes of bradycardia (Heart rate less than 90 bpm).
- •Atrio-ventricular block (second or third degree).
- •Significant congenital heart anomaly, not including patent ductus arteriosus, patent foramen ovale or small ventricular septal defect.
- •Hypotension.
- •Renal failure.
- •Cerebral hemorrhage.
- •Other diseases which contraindicate the use of beta-blockers
- •Newborns with ROP stages more advances than Stage 2 in zone II without plus.
- •Informed Consent from a parent refused. This will mean that an infant automatically will receive standard laser therapy. No data will be used from an infant without Informed Consent.
研究组 & 干预措施
Propranolol
Oral Propranolol administration is the experimental arm of this study
干预措施: Propranolol (Drug)
结局指标
主要结局
The primary aim is to evaluate the safety of propranolol administration
时间窗: Three months
次要结局
- The secondary aim is to evaluate the efficacy of treatment with propranolol for reducing blindness and retinal detachment in newborns with ROP(six months from the beginning of treatment)
研究者
Luca Filippi
Dr. Luca Filippi
Azienda Ospedaliero, Universitaria Meyer