STOP-ROP PARTICIPATING CLINICAL CENTER

说明(调查人员摘要)“本提案请求支持 作为参与的伊利诺伊大学医学院 阈值前辅助治疗氧疗中心 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招募12名合格婴儿的能力 年。该中心将与学习总部一起参加#年 纽约罗切斯特和埃默斯公司的协调中心 在马里兰州，并将遵守研究设计和手册 业务将由总部和总部分别提交 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 估计有3400名早产儿出现严重的视觉后遗症 美国每年的幸存者，尽管人们普遍使用 冷冻疗法。早产儿的病例对照研究，轶事 成功氧疗ROP的报道和研究 在实验模型中进行的研究表明，慢性(长达数周) 康复过程中的低氧与视网膜病变有关， 进步而不是倒退。这一假设也得到了 增殖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变。 因此，我们建议检验“补充氧气”这一假说 阈值前ROP的处理将导致至少减少一个 在单眼或双眼婴儿进展到 严重ROP(阈值)‘ 发展为中度ROP的婴儿(如冷冻中所定义的阈值前) ROP研究)将接受连续脉搏血氧饱和度监测 并被随机分配给两个人中的一个 规定的含氧量：常规与补充。他们的ROP 状态将被前瞻性地测量和记录，主要的 结果将是进展到ROP门槛的婴儿的比例 至少在一只眼睛里。后续追踪将持续三个月。 预计足月分娩的时间。预计的样本量为 与20-30个参与中心的2-3年招生计划兼容。 如果这种方法被证明是有效的，额外的氧气也 预计将从减少相关的肺心病中受益 并伴有支气管肺发育不良，常见于这些婴儿。

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."