CRYO-ROP PARTICIPATING CENTER

CRYO-ROP 参与中心

• 批准号: 3551725
• 负责人: RAND SPENCER
• 金额: $ 10.57万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1985
• 资助国家: 美国
• 起止时间: 1985-09-30 至 1989-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3551725
• 关键词: blindness; case history; cooperative study; cryotherapy; disease /disorder prevention /control; human subject; human therapy evaluation; premature infant human; retina disorder

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: (a) 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 1251 g). In this proposal we document the ability of our group of ophthalmologists and neonatologists to enroll, each year, 260 very low birth weight infants who have survived for at least 28 days in the natural history study. We anticipate that 13 of these infants will also develop retinopathy of prematurity severe enough to become eligible for enrollment to the clinical trial, and that an additional 5 patients will be referred to our center for enrollment to the trial.

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 基本上包括两个研究部分：(A)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医生小组的能力 和新生儿专家每年招募260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 预计这些婴儿中的13人也会患上视网膜病变 早产儿严重到有资格参加临床试验 试验，另外5名患者将被转介到我们中心进行治疗 注册参加试验。