STOP-ROP PARTICIPATING CLINICAL CENTER

STOP-ROP 参与临床中心

• 批准号: 2647989
• 负责人: MICHAEL J SHAPIRO
• 金额: $ 18.69万
• 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/2647989
• 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（研究者摘要）"本提案要求支持 伊利诺伊大学医学院作为参与者 阈前辅助治疗氧中心 早产儿视网膜病变（STOP-ROP）研究。申请文件 该中心的能力，以招募预计12个合格的婴儿， 年该中心将与研究总部一起参加 罗切斯特，纽约和EMMES公司协调中心 在马里兰州，并将遵守研究设计和手册 将由总部单独提交的业务， 协调中心。 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，尽管人们接受使用 冷冻疗法。早产儿病例对照研究，轶事 用氧气成功治疗ROP的报告和研究 在实验模型中进行的研究表明，慢性（长达数周） 愈合过程中的缺氧与视网膜病有关， 进步而不是倒退。这一假设也得到了 增生性视网膜病变与视网膜缺血的关系 其他疾病如糖尿病或镰状细胞视网膜病。 因此，我们提出了测试的假设，"补充氧气， 阈值前ROP的治疗将导致降低至少一个 在一只或两只眼睛进展到 严重ROP（阈值）。' 发生中度ROP的婴儿（如《儿童权利公约》中定义的阈值前， ROP研究）将接受连续脉搏血氧饱和度监测 并随机分配到两个时间点中的一个 规定的氧气水平：常规vs补充。ROP 将前瞻性地衡量和记录状况， 结果将是进展到阈值ROP的婴儿比例 至少一只眼睛。随访将持续到三个月后 预计足月分娩时间。预计样本量为 与20 - 30家参与中心的2 - 3年入组兼容。 如果这种方法被证明是有效的，额外的氧气也是有效的。 预计将通过减少肺心病相关 在这些婴儿中经常观察到支气管肺发育不良。"