THERAPEUTIC OXYGEN FOR PRETHRESHOLD RETINOTHERAPY OF PREMATURITY

早产儿阈值前视网膜治疗的治疗性氧气

• 批准号: 6278957
• 负责人: JAMES LEMONS
• 金额: $ 1.68万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6278957
• 关键词: clinical research; clinical trials; human subject; human therapy evaluation; infant human (0-1 year); oximetry; oxygen therapy; retinopathy of prematurity

Rationale: Retinopathy of Prematurity (ROP) remains a serious public health problem causing significant visual sequelae. It is estimated that 2,060 premature survivors in 1991 in the United States would be adversely affected by ROP, despite the now recognized use of Cryotherapy (estimates prior to Cryotherapy would have been 4,480). Case control studies in premature infants, anecdotal reports of successful treatment of moderately severe ROP with oxygen, and studies conducted in an animal model which induced chronic (weeks-long) hypoxia by breathing 13% inspired oxygen (mean PaO2=38) during the model's healing process, suggest that hypoxia may be a critical factor associated with and perhaps influencing cases that progress rather than regress. This hypothesis is supported by the association of proliferative retinopathies with retinal hypoxia in other disorders such as diabetic or sickle cell retinopathy. These data justify testing of the hypothesis that Supplemental Therapeutic Oxygen for Prethreshold ROP (STOP-ROP) will reduce, by at least one third, the number of infants with one or both eyes progressing to Threshold ROP. Design: This is a randomized blinded multicenter study utilizing 24 centers. 880 infants who develop Prethreshold ROP (as defined by STOP- ROP, modified from the CRYO-ROP study) will receive continuous pulse oximetry saturation monitoring and be randomly assigned to oxygen administration at one of two specified oxygen levels, "conventional" with pulse oximetry of 89-94% saturation vs "supplemental" with pulse oximetry of 96-99% saturation . Their ROP status will be measured and recorded prospectively, and the primary outcome variable will be the proportion of infants who progress to Threshold ROP in at least one eye by 3 months after their expected date of full term delivery. Secondary outcome measures include other ophthalmic (e.g. retinal detachment, macular ectopia) and neonatal outcomes (e.g. growth, pulmonary status, length and cost of hospital stay). The projected sample size is compatible with a 2-3 year enrollment.

理由：早产儿视网膜病变 (ROP) 仍然是一个严重的公众问题 健康问题导致严重的视觉后遗症。 估计 1991 年美国有 2,060 名早产幸存者将受到不利影响 尽管现在公认使用冷冻疗法（估计 冷冻疗法之前为 4,480）。 病例对照研究 早产儿，成功治疗中度早产儿的轶事报告 严重的 ROP 需要吸氧，并且在动物模型中进行的研究表明 通过呼吸 13% 吸入氧引起慢性（数周）缺氧 (平均PaO2=38)模型愈合过程中，提示缺氧 可能是与案件相关并可能影响案件的关键因素 即进步而不是倒退。 这一假设得到了支持 其他疾病中增殖性视网膜病与视网膜缺氧的关联 糖尿病或镰状细胞性视网膜病等疾病。 这些数据证明 检验补充治疗性氧气的假设 阈值 ROP (STOP-ROP) 将减少至少三分之一的数量 一只或双眼进展到 ROP 阈值的婴儿数量。 设计：这是一项随机盲法多中心研究，利用 24 中心。 880 名婴儿出现阈值前 ROP（根据 STOP- ROP（根据 CRYO-ROP 研究修改）将接收连续脉冲 血氧饱和度监测并随机分配吸氧 在两个指定的氧气水平之一进行管理，“常规” 脉搏血氧饱和度为 89-94% 与“补充”脉搏血氧饱和度相比 96-99% 饱和度。 他们的 ROP 状态将被测量和记录 前瞻性地，主要结果变量将是 3 个月内至少一只眼睛进展到阈值 ROP 的婴儿 在他们的预计足月分娩日期之后。 次要结果 措施包括其他眼科（例如视网膜脱离、黄斑 异位）和新生儿结局（例如生长、肺部状况、身长和 住院费用）。 预计的样本量与 2-3年入学。