SURFACTANT REPLACEMENT IN FULL TERM NEWBORNS WITH RESPIRATORY FAILURE

呼吸衰竭足月新生儿的表面活性剂替代

• 批准号: 5217800
• 负责人: ROBERT A SINKIN
• 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/5217800
• 关键词: clinical research; clinical trials; human subject; human therapy evaluation; infant human (0-1 year); pulmonary surfactants; respiratory disorder chemotherapy; respiratory distress syndrome of newborn

This is a multicenter randomized study of multiple dose, exogenous surfactant in full term infants with moderate ventilatory failure who have adverse progression of disease. Infants will be randomized to control and surfactant groups only if they are stable. All treatment after randomization will be administered by individuals blind to assignment. The primary outcome variable will be adverse progression of disease defined by blood gas measures and increased use of ventilary support. The sample size needed to detect a 40% reduction in adverse progression is 206. Support from the GCRC is being sought only for data management.

这是一项多中心随机研究， 表面活性剂在中度排便失败足月婴儿中的应用， 有不利的疾病进展。 婴儿将被随机分配至 控制和表面活性剂基团，只要它们是稳定的。 所有治疗 随机化后，将由对以下内容设盲的个体进行给药 派任 主要结局变量将是以下不良进展： 通过血气测量和增加使用维生素C来定义的疾病 支持. 检测不良反应减少40%所需的样本量 进步206 仅在数据方面寻求全球区域中心的支持 管理