STOP ROP PARTICIPATING CLINICAL CENTER

描述（研究者摘要）“这是一个建议， 纽约作为多中心补充的参与中心 早产儿阈值前视网膜病变的治疗氧（STOP- ROP）研究。 申请书上写着这个中心的招募能力 a预计每年有16名合格婴儿。 本中心将参与 研究总部位于罗切斯特，纽约， 位于马里兰州的EMMES公司。 研究设计和手册 总部将单独提交业务活动计划， 协调中心。 早产儿视网膜病变（ROP）是一个严重的公共卫生问题 造成严重的视力后遗症，估计有3,400名早产儿， 婴儿幸存者每年在美国，尽管接受使用 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 在模型中进行的研究表明， 愈合过程与视网膜病变有关 而不是倒退。 这一假设也得到了 增生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。 因此，我们建议检验以下假设： 阈值前ROP的治疗将导致至少减少 三分之一的婴儿有一只或两只眼睛进展到 需要冷冻治疗的ROP。' 发生中度ROP的婴儿（根据CRYO-ROP中定义的阈值前） 研究）将接受连续脉搏血氧饱和度监测， 在两个指定的时间点之一随机分配给氧 氧气水平：常规（89- 94%饱和度）vs补充 （96- 99%饱和度）。 他们的ROP状态将被测量， 前瞻性记录，主要结局变量为 至少一只眼睛进展到阈值ROP的婴儿比例。 随访将持续到预计时间后的三个月。 足月分娩。 预计的样本量与2-3 20- 30家临床试验机构的年入组。 如果这种方法被证明是有效的，额外的氧气也是有效的。 预期通过减少肺心病而使这些婴儿受益 与支气管肺发育不良有关，经常在这些 孩子"

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."