Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 649
- 试验地点
- 18
- 主要终点
- Progression from moderate to severe ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery
研究概览
简要总结
The purpose of this trial was to determine the efficacy and safety of supplemental therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce the probability of progression to threshold ROP and the need for peripheral retinal ablation.
详细描述
Retinopathy of prematurity (ROP) is an abnormal growth of the blood vessels in the eye that occurs primarily in very premature infants. Eye development occurs normally in the womb; in infants born prematurely, however, the blood vessels must finish developing outside the protective environment of the uterus. Retinopathy of prematurity (also known as retrolental fibroplasia) is a leading cause of blindness and other vision impairments (myopia, strabismus, and amblyopia) in children, both in developed and developing countries.
This study was a randomized trial comparing the effects of 2 oxygenation strategies on the progression of ROP. Infants with prethreshold ROP in at least one eye were eligible for the study. Enrolled infants were randomized to receive either conventional oxygenation at a pulse oximetry target of 89% to 94%, or supplemental oxygen to achieve a pulse oximetry target range of 96% to 99%. Infant were placed on continuous pulse oximetry monitoring and to maintain oxygen saturation, as much as possible, in the assigned target range.
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
- None
入排标准
- 年龄范围
- — 至 48 Hours(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with prethreshold retinopathy of prematurity, confirmed by 2 certified ophthalmologic exams
- •Median pulse oxygen saturation <94% in room air
- •Median pulse oxygen saturation can be kept safely >96% on oxygen/ventilator
排除标准
- •No fatal congenital anomaly or congenital eye anomaly
结局指标
主要结局
Progression from moderate to severe ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery
时间窗: 3 months of age
Progressing from moderate ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery
次要结局
未报告次要终点
