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: 6291105
• 负责人: JAMES LEMONS
• 金额: $ 0.04万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6291105
• 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：早产视网膜病变（ROP）仍然是一个严重的公共卫生问题，导致视觉后遗症很大。 据估计，尽管目前已公认使用冷冻疗法，但1991年在美国，有2,060名早期幸存者会受到ROP的不利影响（冷冻疗法之前的估计是4,480个）。 过早婴儿的病例对照研究，氧气中适中的ROP成功治疗的轶事报道以及在模型中通过呼吸13％启发的氧气（平均PAO2 = 38）在动物模型中进行的研究，该模型在模型中诱导了慢性（长达几周）的缺氧（长期）缺氧（长期）。康复过程，表明缺氧可能是与进展而不是回归的案例相关的关键因素。 在糖尿病或镰状细胞视网膜病变等其他疾病中，增殖性视网膜病与视网膜缺氧的相关性支持了这一假设。这些数据证明了对prethreshold ROP（停止杆）补充治疗氧的假设的检验是合理的，至少将一只或两只眼睛的婴儿数量减少至少三分之一。设计：这是一项利用24个中心的随机，盲目的多中心研究。 880名开发prethreshold ROP的婴儿（由止回杆定义，从冷冻研究中进行了修改）将接收连续的脉搏血氧仪饱和度监测，并在两个指定的氧气中随机分配给氧气，并通过脉搏血氧仪中的两个指定的氧气水平之一。饱和度为89-94％，脉搏血氧饱和度为96-99％的饱和度。他们的ROP状态将被前瞻性地测量和记录，主要结果变量将是婴儿在预期的完整期限交付日期后至少在一只眼睛中至少一只眼睛中阈值ROP的比例。 次要结局措施包括其他眼科（例如视网膜脱离，黄斑异端）和新生儿结局（例如生长，肺状况，住院时间长度和成本）。 预计样本量与2 - 3年的入学率兼容。