STOP-ROP PARTICIPATING CLINICAL CENTER

STOP-ROP 参与临床中心

• 批准号: 2163657
• 负责人: MICHAEL J SHAPIRO
• 金额: $ 22.51万
• 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 1998-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2163657
• 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）“该提案请求支持 伊利诺伊大学医学院作为参与项目 阈值前补充治疗性氧气中心 早产儿视网膜病变 (STOP-ROP) 研究。申请文件 该中心预计每个中心有能力招募 12 名符合条件的婴儿 年。该中心将与研究总部一起参加 纽约罗彻斯特和 EMMES 公司协调中心 在马里兰州，并将遵守研究设计和手册 业务由总部和 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 3400 名早产儿出现严重视觉后遗症 尽管人们普遍接受使用 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实验表明，慢性（长达数周） 愈合过程中的缺氧与视网膜病变有关 进步而不是倒退。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“补充氧气”这一假设 阈值前 ROP 的治疗将导致至少减少一 患有单眼或双眼的婴儿数量的第三位 严重的 ROP（阈值）。 出现中度 ROP 的婴儿（CRYO- 中定义的阈值） ROP 研究）将接受连续脉搏血氧饱和度监测 并被随机分配到以下两个时间之一进行吸氧 指定的氧气水平：常规与补充。他们的ROP 状态将被前瞻性地测量和记录，并且主要 结果将是进展到阈值 ROP 的婴儿比例 至少在一只眼睛里。随访将持续至三个月后 足月分娩的预计时间。预计样本量为 与 20-30 个参与中心的 2-3 年注册兼容。 如果这种方法被证明有效，额外的氧气也可以 预计将通过减少相关肺心病而受益 在这些婴儿中经常观察到支气管肺发育不良。”