EVALUATION 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评价

• 批准号: 6246080
• 负责人: ADAM A ROSENBERG
• 金额: $ 1.71万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-03-20 至 1997-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6246080
• 关键词: apnea; caffeine; clinical research; drug screening /evaluation; human subject; human therapy evaluation; newborn human (0-6 weeks); premature infant human; respiratory disorder chemotherapy

This is a multi-center 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、安慰剂对照研究 一项平行研究，包含补救治疗期，旨在评价 柠檬酸咖啡因治疗早产儿呼吸暂停 主 可评价的终点是呼吸暂停发作频率降低50%。 一 基于以下假设选择了75例患者的样本量： 在咖啡因治疗的患者中，成功率将为70%或更多，20%或更多。 安慰剂组的成功率较低。 双盲阶段将持续一个 至少48小时。