CLINICAL TRIAL OF STERILE CAFFEINE CITRATE IN TREATMENT OF APNEA OF PREMATURITY

无菌柠檬酸咖啡因治疗早产儿呼吸暂停的临床试验

• 批准号: 5218819
• 负责人: ADAM A ROSENBERG
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/5218819
• 关键词: apnea; caffeine; citrates; clinical research; clinical trials; drug screening /evaluation; human subject; human therapy evaluation; newborn human (0-6 weeks); premature infant human; respiratory disorder chemotherapy

This is a multicenter double-blind, randomized, placebo-controlled parallel study with a rescue phase to evaluate the efficacy and safety of caffeine citrate in the treatment of apnea of prematurity. The primary evaluable endpoint is a 50% decrease in the frequency of apnea spells. A sample size of 75 patients has been chosen based upon the assumption that success among caffeine-treated patients will be 70% or more and 20% or less success in the placebo group. The double-blind phase will last a minimum of 48 hours.

这是一项多中心、双盲、随机、安慰剂对照 评价疗效和安全性的平行研究（含补救阶段） 柠檬酸咖啡因治疗早产儿呼吸暂停 的 主要可评价终点是呼吸暂停频率降低50% 法术 根据以下因素选择了75例患者的样本量： 假设咖啡因治疗患者的成功率为70%， 安慰剂组的成功率为20%或更低。 双盲 这一阶段将持续至少48小时。