STOP ROP PARTICIPATING CLINICAL CENTER

停止 ROP 参与临床中心

• 批准号: 2874499
• 负责人: Beverly Brozanski
• 金额: $ 7.01万
• 依托单位: MAGEE-WOMEN'S HOSPITAL OF UPMC
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-09-30 至 2000-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2874499
• 关键词: clinical research; clinical trials; cooperative study; disease /disorder prevention /control; human subject; human therapy evaluation; longitudinal human study; oximetry; oxygen therapy; patient monitoring device; premature infant human; retinopathy of prematurity

DESCRIPTION (Investigator's Abstract) "This proposal requests support for the Magee-Women's Hospital (Pittsburgh, PA) 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 ten 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 estimated 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 retinopathy 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 propose 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 retinal vascular abnormalities (ROP status) will be measured and recorded prospectively, and the primary outcome variable 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 these infants 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 马吉妇女医院（宾夕法尼亚州匹兹堡）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10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，我们建议检验以下假设： 阈值前ROP的治疗将导致至少减少 三分之一的婴儿有一只或两只眼睛进展到 严重ROP（阈值）。' 发生中度ROP的婴儿（根据CRYO-ROP中定义的阈值前） 研究）将接受连续脉搏血氧饱和度监测， 在两个指定的时间点之一随机分配给氧 氧气水平：常规vs补充。 他们的视网膜血管 将前瞻性地测量和记录异常（ROP状态）， 主要的结果变量将是婴儿的比例， 在至少一只眼睛中进展到阈值ROP。 随访将持续 在预计的全期交付时间之后的三个月内。 的 预计样本量与2-3年入组兼容， 20-30个参与中心。 如果这种方法被证明是有效的，额外的氧气也是有效的。 预期通过减少肺心病而使这些婴儿受益 与支气管肺发育不良有关， 婴儿。"