STOP-ROP PARTICIPATING CLINICAL CENTER

STOP-ROP 参与临床中心

• 批准号: 2163658
• 负责人: MICHAEL J SHAPIRO
• 金额: $ 22.41万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-09-30 至 2002-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2163658
• 关键词: clinical trials; cooperative study; human subject; human therapy evaluation; oximetry; oxygen therapy; pathologic process; premature infant human; retinopathy of prematurity

DESCRIPTION (Investigator's Abstract) "This proposal requests support for the University of Illinois College of Medicine as a Participating Center in the Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP) Study. The application documents this center's ability to recruit a projected 12 eligible infants per year. This center will participate with the Study Headquarters in Rochester, New York and the Coordinating Center at the EMMES Corporation in Maryland, and will comply with the study design and Manual of Operations which will be submitted separately by the Headquarters and Coordinating Center. Retinopathy of Prematurity (ROP) remains a serious public health problem causing significant visual sequelae in an estimate 3400 premature infant survivors per year in the United States, despite the accepted use of Cryotherapy. Case control studies in premature infants, anecdotal reports of successful treatment of ROP with oxygen, and studies conducted in experimental models demonstrate that chronic (weeks-long) hypoxia during the healing process is associated with retinopathies that progresses rather than regresses. This hypothesis is also supported by the association of proliferative retinopathies with retinal ischemia in other disorders such as diabetic or sickle cell retinopathies. Therefore, we proposed to test the hypothesis that 'Supplemental Oxygen Treatment of Prethreshold ROP will result in a reduction by at least one third in the number of infants with one or both eyes progressing to severe ROP (Threshold).' Infants who develop moderate ROP (Prethreshold as defined in 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 vs supplemental. Their ROP status will be measured and recorded prospectively, and the primary outcome will be the proportion of infants who progress to Threshold ROP in at least one eye. Follow-up will continue to three months following the projected time of full term delivery. The projected sample sizes are compatible with a 2-3 year enrollment with 20- 30 participating centers. Should this approach prove effective, the additional oxygen is also expected to benefit through the reduction of cor pulmonale associated with bronchopulmonary dysplasia often observed in these infants."

描述（调查员的摘要）“该提案请求支持 伊利诺伊大学医学院作为参与 prethreshold的补充治疗氧气中心 早产性（停止杆）研究的视网膜病变。申请文件 该中心能够招募预计的12名合格婴儿 年。该中心将与研究总部参与 罗切斯特，纽约和艾米斯公司的协调中心 在马里兰州，将遵守研究设计和手册 将由总部单独提交的运营 协调中心。 早产视网膜病变（ROP）仍然是一个严重的公共卫生问题 在3400个早产婴儿中引起明显的视觉后遗症 尽管公认使用 冷冻疗法。过早婴儿的案例控制研究 氧气成功治疗ROP的报道和研究 在实验模型中进行的表明，慢性（长达数周） 治愈过程中的缺氧与视网膜病有关 进步而不是回归。该假设也得到了 增殖性视网膜病与视网膜缺血的关联 其他疾病，例如糖尿病或镰状细胞视网膜病。 因此，我们建议检验以下假设：补充氧气 prethreshold ROP的处理将导致至少减少一个 一只或两只眼睛的婴儿人数中的第三 严重的ROP（阈值）。 发展中等ROP的婴儿（在冷冻中定义的prethreshold ROP研究）将接收连续的脉搏血氧仪饱和度监测 并在两个之一中随机分配给氧气 指定的氧气水平：常规与补充。他们的rop 状态将被前瞻性地测量和记录，主要记录 结局将是发展为阈值ROP的婴儿的比例 至少一只眼睛。随访将持续到三个月 完整期限的预计时间。预计样本量是 与20至30个参与中心的2 - 3年兼容。 如果这种方法证明有效，额外的氧气也是 预计通过减少COR肺相关 在这些婴儿中经常观察到支气管肺发育不良。”