STOP-ROP PARTICIPATING CLINICAL CENTER

STOP-ROP 参与临床中心

• 批准号: 2163603
• 负责人: CHARLES C BARR
• 金额: $ 12.48万
• 依托单位: UNIVERSITY OF LOUISVILLE
• 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/2163603
• 关键词: clinical trials; cooperative study; cryotherapy; eye laser surgery; growth /development; hospital length of stay; human subject; human therapy evaluation; oximetry; oxygen therapy; premature infant human; respiratory function; retinopathy of prematurity

DESCRIPTION (Investigator's Abstract): "Rationale: Retinopathy of Prematurity (ROP) remains a serious health problem causing significant visual sequelae in about 3,400 premature survivors per year in the United States, despite the now recognized use of Cryotherapy. Case control studies in premature infants, anecdotal reports of successful treatment of ROP with oxygen, and studies conducted in an animal model demonstrate that chronic (weeks-long) hypoxia induced by breathing 13 percent inspired oxygen (mean PAO2=38) during the model's healing process may be a critical factor associated with and perhaps influencing cases that progress rather than regress. This hypothesis is supported by the association such as diabetic or sickle cell retinopathy.These data support the hypothesis that: 'Supplemental Therapeutic Oxygen for Prethreshold ROP (STOP-ROP) will reduce, by at least one-third, the number of infants with one or both eyes progressing to Threshold ROP.' Infants who develop Prethreshold ROP 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 variable will be the proportion of infants who progress to Threshold ROP in at least one eye by 3 months after their expected date of full term delivery. The projected sample sizes are compatible with a 2-3 year enrollment using 15-25 centers, the study is planned to coordinate efforts for data management, budget, personnel, study forms, and the DSMC with another, complimentary study of light reduction to prevent ROP (LIGHT-ROP). Follow-up will continue to the age of 3 months after each infant's original due date. Outcomes will include the number of infants who require cryotherapy or laser, ophthalmic outcomes, growth, pulmonary status, and length of hospital stay."

描述（研究者摘要）："依据： 早产（ROP）仍然是一个严重的健康问题， 每年约有3，400名早产幸存者出现视力后遗症， 美国，尽管现在公认使用冷冻疗法。 情况 早产儿的对照研究，成功的 用氧气治疗ROP，以及在动物模型中进行的研究 证明呼吸引起的慢性（长达数周）缺氧13 模型愈合期间吸入的氧气百分比（平均PAO2 = 38） 过程可能是一个关键因素， 进步而不是倒退的案例。 这一假设得到了支持 糖尿病或镰状细胞性视网膜病变。这些 数据支持这一假设："补充治疗氧气， 阈值前ROP（STOP-ROP）将减少至少三分之一， 单眼或双眼进展到阈值ROP的婴儿数量。' 发生阈值前ROP的婴儿将接受连续脉搏 血氧饱和度监测，并随机分配到氧气 在两种特定氧水平之一下给药，常规vs 补充。 测量并记录他们的ROP状态 前瞻性地，主要结局变量将是 3个月时至少一只眼睛进展到阈值ROP的婴儿 在其预计的完整交付日期之后。 投影样品 尺寸与使用15 - 25个中心的2 - 3年入组兼容， 计划进行研究，以协调数据管理、预算 人员、研究表格和DSMC以及另一项免费研究 光减少，以防止ROP（光ROP）。 随访将持续 至每名婴儿原定预产期后3个月。 成果 将包括需要冷冻或激光治疗的婴儿人数， 眼科结局、生长、肺部状态和住院时间 留下吧"