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(南瓜)临床试验将探索一种新的儿科循环支持设备为患有先天性和获得性心血管疾病的婴儿、新生儿和幼儿(25公斤)提供治疗的潜在好处，这些儿童经历了心肺衰竭和循环衰竭。试验中使用的设备，婴儿Jarvik 2015 VAD，是为了解决循环支持设备的许多已知缺陷而开发的，并专门为幼儿和婴儿提供循环支持。这项试验旨在提供临床证据，用于向美国食品和药物管理局(FDA)提出人道主义设备豁免申请，以获得监管部门对该设备的批准，该设备已作为南瓜临床前合同计划的一部分开发。本任务单的目的是管理临床站点试验先锋阶段的实施。

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.