IGF::OT::IGF - R&D, PUMPS FOR KIDS, INFANTS, AND NEONATES (PUMPKIN) CLINICAL TRIAL - DATA & CLINICAL COORDINATING CENTER

儿童、婴儿和新生儿泵（PumpKIN）临床试验将探索一种新型儿科循环支持装置对患有先天性和获得性心血管疾病并经历心肺衰竭和循环衰竭的婴儿、新生儿和幼儿（<25公斤）的潜在益处。在试验中使用的设备是Infant Jarvik 2015 VAD，它的开发是为了解决循环支持设备的许多已知缺点，专门为幼儿和婴儿提供循环支持。该试验旨在提供临床证据，用于向美国食品和药物管理局（FDA）申请人道主义设备豁免，以获得该设备的监管批准，该设备已被开发为PumpKIN临床前合同项目的一部分。本任务令的目的是在审判期间为审判提供行政支持。

The Pumps for Kids, Infants, and Neonates (PumpKIN) clinical trial will explore the potential benefit of therapy offered by a novel pediatric circulatory support device to infants, neonates, and young children (<25 kg) with congenital and acquired cardiovascular disease who experience cardiopulmonary failure and circulatory collapse. The device to be used in the trial, the Infant Jarvik 2015 VAD, has been developed to address many of the known shortcomings of circulatory support devices and designed specifically to provide circulatory support for young children and infants. The trial is intended to provide clinical evidence to be used in a Humanitarian Device Exemption application to the U.S. Food and Drug Administration (FDA) for regulatory approval of the device that has been developed as part of the PumpKIN pre-clinical contract program. This purpose of this task order is to provide administrative support for the trial over the duration of the trial.