STOP-ROP PARTICIPATING CLINICAL CENTER

描述(研究人员摘要)：“基本原理：视网膜病变 早产(ROP)仍然是一个严重的健康问题，导致 中国每年约有3400名早产儿出现视力后遗症 美国，尽管现在公认使用冷冻疗法。案例 早产儿对照研究，成功的轶事报道 ROP的氧疗及动物模型研究 证明呼吸引起的慢性(长达数周)低氧13 模型愈合期间吸入氧气的百分比(平均PaO2=38) 流程可能是与之相关甚至可能影响到的关键因素 进步而不是倒退的案例。这一假设得到了支持 如糖尿病或镰状细胞视网膜病变。这些 数据支持这样的假设：补充治疗性氧气对 阈值前ROP(停止ROP)将减少至少三分之一 单眼或双眼的婴儿进展到阈值ROP的数量。 出现阈值前ROP的婴儿将接受连续脉冲 血氧饱和度监测和随机分配给氧 在两个特定氧气水平中的一个给药，常规与 补充。他们的ROP状态将被测量和记录 前瞻性的，主要的结果变量将是比例 至少一只眼睛在3个月内进展到阈值ROP的婴儿 在他们预期的完全交付日期之后。投射样本 规模与使用15-25个中心的2-3年招生计划兼容， 计划进行研究，以协调数据管理、预算、 人员、学习表格和另一项免费学习的dsmc 减少光线以防止ROP(Light-ROP)。后续工作将继续进行 至每个婴儿原定预产期后3个月的年龄。结果 将包括需要冷冻治疗或激光治疗的婴儿数量， 眼科结果、生长、肺部状况和住院时间 留下来吧。“

DESCRIPTION (Investigator's Abstract): "Rationale: Retinopathy of Prematurity (ROP) remains a serious health problem causing significant visual sequelae in about 3,400 premature survivors per year in the United States, despite the now recognized use of Cryotherapy. Case control studies in premature infants, anecdotal reports of successful treatment of ROP with oxygen, and studies conducted in an animal model demonstrate that chronic (weeks-long) hypoxia induced by breathing 13 percent inspired oxygen (mean PAO2=38) during the model's healing process may be a critical factor associated with and perhaps influencing cases that progress rather than regress. This hypothesis is supported by the association such as diabetic or sickle cell retinopathy.These data support 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.' Infants who develop Prethreshold ROP will receive continuous pulse oximetry saturation monitoring and be randomly assigned to oxygen administration at one of two specified oxygen levels, conventional vs supplemental. 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. The projected sample sizes are compatible with a 2-3 year enrollment using 15-25 centers, the study is planned to coordinate efforts for data management, budget, personnel, study forms, and the DSMC with another, complimentary study of light reduction to prevent ROP (LIGHT-ROP). Follow-up will continue to the age of 3 months after each infant's original due date. Outcomes will include the number of infants who require cryotherapy or laser, ophthalmic outcomes, growth, pulmonary status, and length of hospital stay."