SURFACTANT REPLACEMENT IN FULL TERM NEWBORNS WITH RESPIRATORY FAILURE

这是一项关于多剂量外源性的多中心随机研究 肺表面活性物质在足月儿中度呼吸衰竭中的应用 有疾病的不利进展。婴儿将被随机分配到 控制基团和表面活性剂基团只有在它们稳定的情况下才能使用。所有治疗 随机化后将由盲人给药 任务。主要的结果变量将是不良进展 通过测量血气和增加使用呼吸机来定义疾病 支持。检测到不良反应减少40%所需的样本量 进度是206。仅在数据方面寻求GCRC的支持 管理层。

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.