CRYO-ROP PARTICIPATING CENTER

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，我们记录了我们眼科医生小组的能力， 和产科医生每年招募120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6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8名患者将被转介到我们的中心， 入组试验。

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 ophthalmologists and neonatologists to enroll, each year, 120 very low birth weight infants who have survived for at least 28 days in the natural history study. We anticipate that 6 of these infants will also develop retinopathy of prematurity severe enough to become eligible for enrollment to the clinical trial, and that an additional 8 patients will be referred to our center for enrollment to the trial.