STOP-ROP PARTICIPATING CLINICAL CENTER

STOP-ROP 参与临床中心

• 批准号: 2163849
• 负责人: CYNTHIA Hamlet COLE
• 金额: $ 20.12万
• 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 1997-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2163849
• 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）是一个严重的公共卫生问题 导致3400名早产儿出现严重的视力后遗症 在美国，尽管使用了冷冻疗法， 早产儿的病例对照研究，成功的 用氧气治疗ROP，以及在实验模型中进行的研究 证明慢性（长达数周）缺氧在愈合过程中， 与视网膜病变的进展有关，而不是退化。这 增殖性视网膜病与视网膜病变的关系支持这一假说。 其他疾病如糖尿病或镰状细胞性视网膜缺血 视网膜病变我们建议测试假设：“补充 阈值前R 0 P的氧治疗将导致降低 至少三分之一的婴儿的一只或两只眼睛进展 至严重ROP（阈值）。" 发生中度ROP（阈值前）的婴儿将接受持续的 脉搏血氧饱和度监测，并随机分配到氧气 在两种特定氧水平之一下给药：常规vs 补充。测量并记录他们的ROP状态 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 在预计的全期交付时间之后继续三个月。 预计样本量与2-3年入组20- 30个参与中心 本提案要求支持新英格兰医疗中心（NEMC）作为 阈前辅助治疗氧参与中心 早产儿视网膜病（ST 0 P-R 0 P）研究。受试者将入 与波士顿医院相关的两个新生儿重症监护室（NICU） NEMC和波士顿市医院（BCH）的围产期中心（BPC）。NEMC是 第一申请人，BCH的参与是通过一个代理人。 1992年，随着全国产科护理和妇幼保健高风险产科服务的扩大， BPC将能够招募至少16名合格的婴儿 （10个来自NEMC，6个来自BCH）。密切眼科和新生儿 协作，以及人员和护理人员的以往经验 多中心临床试验支持BPC能够 有助于STOP-ROP的成功。BPC通过NEMC和BCH将 参加研究总部（罗切斯特，纽约）， 协调中心在马里兰州的EMMES公司，并将遵守 研究设计和程序手册（单独提交 总部和协调中心）。