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

NIH RePORTER · NIH · N01 · $1,245,887 · view on reporter.nih.gov ↗

Abstract

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.

Key facts

NIH application ID
10490210
Project number
268201200001I-P00008-26800006-1
Recipient
NEW ENGLAND RESEARCH INSTITUTES, INC.
Principal Investigator
SANDI SIAMI
Activity code
N01
Funding institute
NIH
Fiscal year
2021
Award amount
$1,245,887
Award type
Project period
2017-03-31 → 2022-09-29