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

儿童、婴儿和新生儿用胰岛素泵（PumpKIN）临床试验将探索一种新型儿科循环支持装置为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 kg）提供治疗的潜在益处。试验中使用的装置，即婴儿Jarvik 2015 VAD，是为了解决循环支持装置的许多已知缺点而开发的，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，用于向美国食品药品监督管理局（FDA）申请人道主义器械豁免，以获得作为PumpKIN临床前合同项目一部分开发的器械的监管批准。本任务指令旨在管理临床研究中心Vanguard试验阶段的实施。

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 manage the implementation of the Vanguard Phase of the trial at the clinical sites.