STOP-ROP--A MULTICENTER TRIAL OF OXYGEN FOR ROP

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2060例早产儿中造成严重的视觉后遗症 美国每年的幸存者或4400名没有 冷冻疗法。冷冻治疗并不总是成功的，消融显著 视网膜的一部分，其长期后遗症尚不清楚。案例 氧AS治疗ROP的对照研究和轶事报道 在动物模型中进行的研究表明，慢性 (长达数周)ROP愈合过程中的低氧可能是一个关键因素 决定哪些ROP病例痊愈的因素，这一假设得到了 其他增生性视网膜病变与视网膜缺氧的关系 视网膜病变，如糖尿病视网膜病变。具有讽刺意味的是，对 未成熟婴儿过多吸氧导致ROP 视网膜导致了严格的氧气管理。早产儿患有 不稳定的心肺状态和这一最低氧气水平 服药后可经历间歇性低氧导致肺 高血压和肺心病。在实践中，氧气被给予更多 一旦这些婴儿的视网膜完全发育完全，就可以慷慨地给予他们 血管化，因此没有ROP的风险。这些数据证明了 对“补充治疗性氧疗”假设的检验 阈值前ROP(Stop-ROP)将减少至少三分之一的 婴儿进展到ROP门槛。 此建议书是该测试的主要申请，并与 《程序手册》以及协调和协调委员会的提案 参与中心。出现阈值前ROP(如定义)的婴儿 在冷冻-ROP研究中)将获得持续的氧饱和度 监测，并随机分配给氧在两个 规定氧水平，常规(脉搏血氧计89-94% 饱和)与补充(脉搏血氧饱和度为96-99%)。初级阶段 结果变量将是进展到 门槛ROP。预计样本大小为880，与3 15-30个中心的年度招生人数；将进行中期分析。 将收集关于特定眼科、新生儿和费用结果的数据 前瞻性地通过3个月校正胎龄。如果这样的话 治疗证明是有效和安全的，婴儿中度 ROP阈值前(每年近5000)将从它的使用中受益，两者 在他们的眼科和新生儿结果中。

Retinopathy of Prematurity (ROP) remains a serious public health problem causing significant visual sequelae in an estimated 2,060 premature survivors per year in the United States or 4,400 without the benefits of Cryotherapy. Cryotherapy is not always successful, ablates a significant portion of the retina, and its long term sequelae are unknown. Case control studies and anecdotal reports of treatment of ROP with oxygen as well as studies conducted in an animal model demonstrate that chronic (weeks-long) hypoxia during the ROP healing process may be a critical factor in determining which cases of ROP heal, an hypothesis supported by the association with retinal hypoxia in other proliferative retinopathies, such as diabetic retinopathy. Ironically, concerns over precipitating ROP by giving too much oxygen to infants with immature retinae has lead to strict oxygen management. Premature infants with unstable cardiopulmonary status and this minimal level of oxygen administration can experience episodic hypoxia leading to pulmonary hypertension and cor pulmonale. In practice, oxygen is given more liberally to these infants as soon as their retinae become fully vascularized, and thus free from the risk of ROP. These data justify testing of the hypothesis that "Supplemental Therapeutic Oxygen for Prethreshold ROP (STOP-ROP) will reduce by at least 1/3 the number of infants progressing to Threshold ROP." This proposal is the Lead Application for that test and is submitted with the Manual of Procedures, and proposals from the Coordinating and Participating Centers. Infants who develop Prethreshold ROP (as defined in the CRYO-ROP study) will receive continuous oxygen saturation monitoring, and randomly assigned oxygen administration at one of two specified oxygen levels, conventional (pulse oximetry of 89-94% saturation) vs supplemental (pulse oximetry of 96-99%). The primary outcome variable will be the proportion of infants who progress to Threshold ROP. The projected sample size of 880 is compatible with a 3 year enrollment in 15-30 centers; interim analyses will be conducted. Data on specific ophthalmic, neonatal and cost outcomes will be collected prospectively through 3 months corrected gestational age. Should this treatment prove to be both efficacious and safe, infants with moderate ROP prethreshold (nearly 5000 each year) would benefit from its use, both in their ophthalmic and neonatal outcomes.