MULTICENTER TRIAL OF CRYOTHERAPY FOR RETINOPATHY OF PREM

这是一份成为中国合作学习中心之一的申请 冷冻疗法治疗早产儿视网膜病变的研究低温ROP研究 主要包括两个研究部分：(1)临床试验 冷冻治疗青光眼的安全性和有效性 严重，高风险，ROP；和(2)自然历史研究(符合 早产儿视网膜病变的国际分级) 极低出生体重儿(小于1251克)。 在这份提案中，我们记录了我们的眼科专家小组的能力 和新生儿科医生每年招募101名极低出生体重儿 他们在自然历史研究中存活了至少28天。我们 预计其中14名婴儿还会患上视网膜病变 早产儿严重到有资格参加临床试验 试验，另外20名患者将被转介到我们中心 为参加审判做准备。 CRYO-ROP研究由俄勒冈健康中心厄尔·A·帕尔默医学博士主持 科学大学(合作协议奖1U01EY05874-01)。这个 协调中心由罗伯特·J·哈迪博士在 德克萨斯大学健康科学中心，休斯顿。

This is an application to become one of the cooperating study centers in the Cryotherapy for Retinopathy of Prematurity Study. The CRYO-ROP Study consists of essentially two research components: (1) a clinical trial of the safety and efficacy of cryotherapy in reducing blindness in eyes with severe, high risk, ROP; and (2) a study of the natural history (in accord with the international classification of ROP) of retinopathy of prematurity in very low birth weight infants (less than 1251g). In this proposal we document the ability of our group of opthalmologists and neonatologists to enroll, each year, 101 very low birth weight infants who have survived for at least 28 days in the natural history study. We anticipate that 14 of these infants will also develop retinopathy of prematurity severe enough to become eligible for enrollment to the clinical trial, and that an additional 20 patients will be referred to our center for enrollment to the trial. The CRYO-ROP Study is chaired by Earl A. Palmer, M.D., at the Oregon Health Sciences University (Cooperative Agreement Award 1U01EY05874-01). The Coordinating Center is directed by Robert J. Hardy, Ph.D., at The University of Texas Health Sciences Center, Houston.