NCT01660620已完成1 期
Topical Betaxolol for the Prevention of Retinopathy of Prematurity
Smith-Kettlewell Eye Research Institute0 个研究点目标入组 23 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 主要终点
- development of apnea and or bradycardia
研究概览
简要总结
We hypothesize that topical betaxolol will reduce the development of severe retinopathy of prematurity.
详细描述
The drug is administered twice a day between 32 and 35 weeks gestational age, at a t ime when ROP is most likely to arise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 32 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<1251 grms birth weight
排除标准
- •ocular defect
研究组 & 干预措施
betaxolol
Experimental
betaxolol 0.25% 2 per day for 3 weeks
干预措施: Betaxolol (Drug)
placebo
Placebo Comparator
masked labeling also 2 per day administration
干预措施: topical betaxolol (Drug)
结局指标
主要结局
development of apnea and or bradycardia
时间窗: 3 weeks
babies were monitored and HR/RR monitored and recorded by masked observers, periodically
次要结局
- development of ROP requiring treatment(7 weeks)
研究者
William V Good, MD
Administrator
Smith-Kettlewell Eye Research Institute
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