STOP ROP PARTICIPATING CLINICAL CENTER

停止 ROP 参与临床中心

• 批准号: 2874502
• 负责人: CYNTHIA Hamlet COLE
• 金额: $ 16.07万
• 依托单位: TUFTS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 1993
• 资助国家: 美国
• 起止时间: 1993-09-30 至 2001-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2874502
• 关键词: clinical trials; cooperative study; human subject; human therapy evaluation; oxygen therapy; premature infant human; retinopathy of prematurity

Retinopathy of Prematurity (ROP) remains a serious public health problem causing significant visual sequelae in an estimated 3400 premature infant survivors per year in the United States, despite the 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 retinopathy that progresses rather than regresses. This hypothesis is supported by association of proliferative retinopathies with retinal ischemia in other disorders such as diabetic or sickle cell retinopathies. We proposed to test the hypothesis that: "Supplemental Oxygen Treatment of Prethreshold R0P 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) 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. The primary outcome variable will be the proportion of infants who progress to Threshold ROP in at least one eye. Follow-up will continue three months following the projected time of full term delivery. Projected sample sizes are compatible with a 2-3 year enrollment with 20- 30 participating centers. This proposal requests support for New England Medical Center (NEMC) as a Participating Center in Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (ST0P-R0P) Study. Subjects will be enrolled in the two neonatal intensive care units (NICUs) associated with the Boston Perinatal Center (BPC) at NEMC and Boston City Hospital (BCH). NEMC is the primary applicant, and participation of BCH is through a subcontract. With expansion in the NEMC and BCH high-risk obstetric services in 1992, the BPC will be able to recruit a projected minimum of 16 eligible infants per year (10 from NEMC, 6 from BCH). The close ophthalmologic and neonatal collaboration, and the previous experience of personnel and nursing staff with multicenter clinical trials supports the ability of the BPC to contribute to the success of STOP-ROP. BPC through NEMC and BCH will participate with Study Headquarters in Rochester, New York and Coordinating Center at EMMES Corporation in Maryland, and will comply with study design and Manual of Procedures (submitted separately by Headquarters and Coordinating Center).

早产儿视网膜病变（ROP）仍然是一个严重的公共卫生问题 造成约 3400 名早产儿严重视觉后遗症 尽管使用冷冻疗法，美国每年仍有幸存者。 早产儿病例对照研究，成功的轶事报告 用氧气处理 ROP，以及在实验模型中进行的研究 证明愈合过程中慢性（长达数周）缺氧 与进展而不是消退的视网膜病变有关。这 增殖性视网膜病与以下疾病之间的关联支持了这一假设： 其他疾病（例如糖尿病或镰状细胞病）引起的视网膜缺血 视网膜病变。我们建议检验以下假设：“补充 阈值前 R0P 的氧气处理将导致至少 至少有三分之一的婴儿单眼或双眼出现进展 达到严重的 ROP（阈值）。” 出现中度 ROP（阈值）的婴儿将接受持续治疗 脉搏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给药：常规与 补充。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 至少一只眼睛进展到阈值 ROP 的婴儿。 后续将 在预计足月交付时间后继续三个月。 预计样本量适合 2-3 年的注册，其中 20- 30 个参与中心。 该提案请求支持新英格兰医学中心 (NEMC) 作为 阈值前补充治疗性氧气参与中心 早产儿视网膜病变 (ST0P-R0P) 研究。科目将被录取 与波士顿医院相关的两个新生儿重症监护病房 (NICU) NEMC 围产期中心 (BPC) 和波士顿市医院 (BCH)。 NEMC 是 主申请人，BCH通过分包参与。 随着 1992 年 NEMC 和 BCH 高风险产科服务的扩展， BPC 预计将能够招募至少 16 名符合条件的婴儿 每年（10 个来自 NEMC，6 个来自 BCH）。密切的眼科和新生儿科 协作以及人员和护理人员以前的经验 多中心临床试验支持 BPC 的能力 为 STOP-ROP 的成功做出贡献。 BPC 通过 NEMC 和 BCH 将 参与纽约州罗彻斯特的研究总部 位于马里兰州 EMMES Corporation 的协调中心，并将遵守 研究设计和程序手册（由 总部和协调中心）。