Safety and Efficacy of Propranolol 0.2% Eye Drops in Treating Newborn With Retinopathy of Premature: A Pilot Study (DROP-ROP-0.2%)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 7
- 主要终点
- Incidence rate of progression from stage 1 ROP to zone II stage 2 ROP with plus
研究概览
简要总结
The aim of the present study is to evaluate the safety and efficacy of propranolol 0.2% eye drops in treating preterm newborns with a precocious stage of retinopathy of prematurity (ROP). Preterm newborns (gestational age 23-32 weeks) with a stage 1 ROP will receive propranolol 0.2% eye drops treatment until retinal vascularization will be completed, but no more than 90 days.
Propranolol concentrations will be measured on dried blood spots at the steady state (10th day). Cardiovascular and respiratory parameters will be continuously monitored. Blood samplings checking metabolic, renal and liver functions will be performed periodically, as well as cardiac function, in order to verify the treatment safety. Serial ophthalmological evaluations will be planned to monitor the efficacy of the treatment, the ROP progression and the possible complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm newborns (gestational age 23-32 weeks) with stage 1 ROP
- •A signed parental informed consent
排除标准
- •Newborns with heart failure
- •Newborns with recurrent bradycardia (heart rate < 90 beat per minute)
- •Newborns with second or third degree atrioventricular block
- •Newborns with congenital cardiovascular anomalies, except for persistent ductus arteriosus, patent foramen ovale and small ventricular septal defects
- •Newborns with hypotension
- •Newborns with renal failure
- •Newborns with actual cerebral haemorrhage
- •Newborns with other diseases which contraindicate the use of beta-adrenoreceptor blockers.
- •Newborns with a more severe stage of ROP than stage 1
研究组 & 干预措施
Propranolol 0.2% eye drops
Enrolled preterm newborns will receive propranolol as ophthalmic solution (0.2%). The treatment will be started as soon as the diagnosis of stage 1 ROP is made and will be continue until the development of retinal vascularization is completed, but no more than 90 days. Cardiovascular and respiratory parameters will be continuously monitored. Blood samplings checking metabolic, renal and liver functions will be performed periodically, as well as cardiac function, in order to verify the treatment safety. Propranolol concentrations will be measured on dried blood spots at the steady state (10th day). Serial ophthalmological evaluations will be planned to monitor the efficacy of the treatment, the ROP progression and the possible complications.
干预措施: Propranolol 0.2% eye drops (Drug)
结局指标
主要结局
Incidence rate of progression from stage 1 ROP to zone II stage 2 ROP with plus
时间窗: participants will be followed for the duration of hospital stay, an expected average of 2 months
Incidence rate of progression from stage 1 ROP to zone II stage 3 ROP with plus
时间窗: participants will be followed for the duration of hospital stay, an expected average of 2 months
Plasma concentrations of propranolol at the steady state measured by dried blood spots
时间窗: 10th day of treatment
次要结局
- Number of newborns who progress to Stage 2 without plus ROP(participants will be followed for the duration of hospital stay, an expected average of 2 months)
- Number of newborns who progress to Stage 3 without plus ROP(participants will be followed for the duration of hospital stay, an expected average of 2 months)
- Number of newborns who progress to Stage 5 ROP with total or partial retinal detachment(participants will be followed for the duration of hospital stay, an expected average of 2 months)
- Number of newborns who progress to Stage 4 with total or partial retinal detachment(participants will be followed for the duration of hospital stay, an expected average of 2 months)
- Number of newborns who need vitrectomy(participants will be followed for the duration of hospital stay, an expected average of 2 months)
- Collection of adverse events due to eye drop propranolol treatment(participants will be followed for the duration of hospital stay, an expected average of 2 months)
研究者
Luca Filippi
MD
Azienda Ospedaliero, Universitaria Meyer