STOP ROP PARTICIPATING CLINICAL CENTER

描述(调查人员摘要)“这是对北部地区的一项建议 纽约作为多中心补充中心的参与中心 氧疗治疗早产儿阈值前视网膜病变(Stop- ROP)研究。申请书记录了该中心的招聘能力 预计每年有16名符合条件的婴儿。该中心将参与 研究总部设在纽约罗切斯特，协调中心 位于马里兰州的埃默斯公司。研究设计和手册 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 在估计3400名早产儿中造成严重的视觉后遗症 每年在美国存活的婴儿，尽管被接受使用 冷冻疗法的一部分。早产儿的病例对照研究，轶事 成功氧疗ROP的报道和研究 在模型中进行的研究表明，慢性(长达数周)的缺氧在 愈合过程与进展的视网膜病变有关。 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 需要冷冻治疗的ROP。 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 血氧水平：常规(-94%饱和度)与补充 (96-99%饱和度)。他们的ROP状态将被测量并 前瞻性记录，主要结果变量将是 至少一只眼进展到阈值ROP的婴儿比例。 后续行动将持续到预计时间之后的三个月 全程分娩。预计的样本大小与2-3 年招生，有20-30个参与中心。 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 孩子们。“

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."