STOP ROP PARTICIPATING CLINICAL CENTER

停止 ROP 参与临床中心

• 批准号: 2874503
• 负责人: DALE L. PHELPS
• 金额: $ 5.7万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-01-01 至 2000-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2874503
• 关键词: clinical trials; cooperative study; disease /disorder prevention /control; eye disorder chemotherapy; human subject; human therapy evaluation; oxygen therapy; premature infant human; retinopathy of prematurity

DESCRIPTION (Investigator's Abstract) "This is a proposal for Upstate New York as a Participating Center in the Multicenter Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP- ROP) study. The application documents this center's ability to recruit a projected 16 eligible infants per year. This center will participate with the Study Headquarters in Rochester, New York and the Coordinating Center at EMMES Corporation in Maryland. The study design and Manual of Operations will be submitted separately by the Headquarters and Coordinating Centers. Retinopathy of Prematurity (ROP) remains a serious public health problem causing significant visual sequelae in an estimated 3,400 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 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 ROP requiring cryotherapy.' 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 (89-94 percent saturation) vs supplemental (96-99 percent saturation). Their 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. Followup 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 children."

描述（调查员摘要）“这是一项针对北部地区的提案 纽约作为多中心补充的参与中心 治疗性氧气治疗早产儿阈前视网膜病变（STOP- ROP）研究。 该申请证明了该中心的招聘能力 预计每年有 16 名符合资格的婴儿。 本中心将参与 与纽约州罗彻斯特的研究总部和协调中心 位于马里兰州 EMMES 公司的中心。 研究设计和手册 业务情况由总部单独报送 协调中心。 早产儿视网膜病变（ROP）仍然是一个严重的公共卫生问题 导致约 3,400 名早产儿出现严重视觉后遗症 尽管已接受使用，但美国每年仍有婴儿幸存者 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 在模型中进行的研究表明，在 愈合过程与进展的视网膜病变有关 而不是倒退。 这一假设也得到了支持 增殖性视网膜病与视网膜缺血的关系 其他疾病，例如糖尿病或镰状细胞性视网膜病。 因此，我们建议检验以下假设：“补充氧气 阈值前 ROP 的治疗将导致至少减少 三分之一的单眼或双眼婴儿发展为 ROP 需要冷冻治疗。 出现中度 ROP 的婴儿（CRYO-ROP 中定义的阈值） 研究）将接受连续脉搏血氧饱和度监测和 被随机分配到两个指定的之一接受氧气管理 含氧量：常规（89-94% 饱和度）与补充 （96-99% 饱和度）。 他们的 ROP 状态将被测量并 前瞻性记录，主要结果变量将是 至少一只眼睛进展到阈值 ROP 的婴儿比例。 随访将在预计时间后持续三个月 足额交付。 预计样本量与 2-3 兼容 年招生人数为 20-30 个参与中心。 如果这种方法被证明有效，额外的氧气也可以 预计通过减少肺心病将使这些婴儿受益 与支气管肺发育不良有关，常见于这些疾病 孩子们。”