MULTICENTER TRIAL OF CRYOTHERAPY FOR RETINOPATHY OF PREM

这是一份申请书，申请成为 冷冻疗法治疗早产儿视网膜病变的研究 CRYO-ROP研究 主要包括两个研究部分：（1）临床试验， 冷冻治疗在致盲中的安全性和有效性 重度、高危、ROP;（2）自然史研究（雅阁 与ROP的国际分类）的早产儿视网膜病变 极低出生体重儿（小于1251 g）。 在这份提案中，我们记录了我们的眼科专家小组的能力， 和产科医生每年招募101名极低出生体重婴儿 在自然史研究中存活了至少28天的人。 我们 预计其中14名婴儿也会出现视网膜病变， 早产严重到足以有资格入组临床 试验，另外20名患者将被转介到我们的中心 参加试验。 CRYO-ROP研究由Earl A.帕尔默医学博士，在俄勒冈州健康中心 科学大学（合作协议奖1U 01 EY 05874 -01）。 的 协调中心由Robert J.哈代博士负责，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.