LIFEbubble: development of a novel device to reduce umbilical catheter associated bloodstream infections in neonates

James Wall
22
Dec

LIFEbubble: development of a novel device to reduce umbilical catheter associated bloodstream infections in neonates

: Background Umbilical catheterization in neonates is a lifesaving intervention for premature and critically ill newborns. However, bloodstream infections are at least five times more common in neonates with umbilical catheters (UCs) than in adults with central lines. While many devices exist to prevent bloodstream infections in adults with central catheters, no device to date currently exists to do so in neonates with UCs. The umbilical stump-catheter interface poses unique challenges for the design of a device, including: (1) the UC is inserted through tissue (the umbilical stump) that necroses; (2) the UC is inserted at an angle perpendicular instead of semi-parallel to the skin. In order to satisfy these design constraints and create a device that reduces bloodstream infections in neonates with UCs, the current team designed a device, called LIFEbubble, that aims to enhance stabilization of the UC, prevent bacterial migration by standardizing the process of stabilization, and protect the umbilical stump-umbilical catheter complex to prevent inoculation by caregivers and skin migration of bacteria into the bloodstream. Method and Results To drive initial prototype development, necessity of venting was determined, as complete occlusions of the dying umbilical stump could increase bacterial colonization rates. Human umbilical cord segments were catheterized with sterile UCs and stabilized with non-vented versus vented prototypes and compared to the current standard of care (a tape goal post configuration). These experiments demonstrated that a minimum of 6% of surface area ventilation yields significantly lower bacterial colonization rates than a non-vented prototype (p=0.04). Subsequent vented silicone prototypes were tested against the current standard of care to determine if material and venting would demonstrate non-inferiority in vitro. The experiment was repeated comparing prototype versus current standard of care, which demonstrated an equal infection rate, but had the added benefit of preventing objects, such as fingers, larger than 0.375” in diameter from touching the umbilical catheter-stump interface. The team is currently in the process of testing UC stabilization features in the prototype to ensure that at minimum it provides equal stabilization to the current standard of care. This will be done by testing translation of the UC with the prototype versus the current standard of care at a given force. By enhancing catheter stabilization, we aim to prevent translation of bacteria from the catheter into the bloodstream. Finally, methods of securing the device with adequate adhesion to neonatal skin without damaging fragile skin, but providing an occlusive barrier to migrating bacteria is currently undergoing testing in vitro. Conclusion While the umbilical catheter-stump interface makes device development more challenging, our data show that it is possible to create a device that standardizes stabilizing umbilical catheters with the goal of reducing umbilical catheter associated infections in neonates. We aim to have a product for human testing in early 2016, with subsequent availability to the market.