STOP-ROP PARTICIPATING CLINICAL CENTER

STOP-ROP 参与临床中心

• 批准号: 2163848
• 负责人: CYNTHIA Hamlet COLE
• 金额: $ 25.95万
• 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/2163848
• 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 在大约3400名早产儿中造成严重的视觉后遗症 尽管使用了冷冻疗法，但美国每年仍有幸存者。 早产儿的病例对照研究，成功的轶事报道 ROP的氧疗及实验模型研究 证明在康复过程中慢性(长达数周)的缺氧 与进行性视网膜病变有关，而不是退行性。这 增殖性视网膜病变与 糖尿病或镰状细胞等其他疾病的视网膜缺血 视网膜病变。我们建议检验这一假设：“补充 阈值前R0P的氧气处理将导致At减少 单眼或双眼发育的婴儿数量中至少有三分之一 严重ROP(临界值)。 出现中度ROP(阈值前)的婴儿将继续接受 脉搏血氧饱和度监测和随机分配给氧 在两种指定氧气水平中的一种给药：常规与 补充。他们的ROP状态将被测量和记录 未雨绸缪。主要的结果变量将是 进展到ROP阈值的婴儿至少有一只眼。后续行动将 在预计的足月分娩时间后继续三个月。 预计样本规模与2-3年期招生人数兼容，20- 30个参赛中心。 该提案请求支持新英格兰医疗中心(NEMC)作为 阈值前补充氧疗参与中心 早产儿视网膜病变(ST0P-R0P)研究。各科目将参加 与波士顿有关的两个新生儿重症监护病房(NICU) NEMC的围产期中心(BPC)和波士顿城市医院(BCH)。NEMC是 主要申请者，BCH通过分包合同参与。 1992年，随着NEMC和BCH高危产科服务的扩大， BPC将能够招募至少16名符合条件的婴儿 每年(NEMC 10人，BCH 6人)。近距离眼科和新生儿 协作，以及以前的人员和护理人员的经验 通过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 与位于纽约罗切斯特的学习总部一起参与 位于马里兰州埃默斯公司的协调中心，并将遵守 研究设计和程序手册(由 总部和协调中心)。