STOP-ROP PARTICIPATING CLINICAL CENTER

说明(调查人员摘要)“本提案请求支持 马吉妇女医院(宾夕法尼亚州匹兹堡)作为参与者 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 该中心预计每名婴儿招募10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 在大约3400名早产儿中造成严重的视觉后遗症 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) 愈合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，我们建议检验这一假设：“补充氧气 阈值前ROP的处理将导致至少减少 1/3的单眼或双眼婴儿发育到 严重ROP(阈值)‘ 发展为中度ROP(低温ROP中定义的阈值前)的婴儿 研究)将接受连续脉搏血氧饱和度监测和 在指定的两种情况下随机分配给氧 氧气水平：常规与补充。他们的视网膜血管 将前瞻性地测量和记录异常情况(ROP状态)， 而主要的结果变量将是婴儿中 至少一只眼达到阈值ROP。后续工作将继续进行 至预计足月分娩后三个月。这个 预计样本规模与2-3年制的注册人数相兼容 20-30个参赛中心。 如果这种方法被证明是有效的，额外的氧气也 有望通过减少肺心病使这些婴儿受益 与支气管肺发育不良相关，常见于 婴儿。“

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."