SBIR Phase I: A Medical Device to Protect and Stabilize Umbilical Catheters in the Neonatal Intensive Care Unit

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to standardize the process of securing and protecting umbilical cord catheters. These catheters are inserted into newborn babies in the neonatal intensive care unit (NICU) and are used to provide life-saving nutrients and medication directly into their bloodstream. Unfortunately, the infection rate associated with these catheters is among the highest in the healthcare system. There is an important need for a simple medical device that reduces the risk of infection. A reduction in infection rate would save hospitals hundreds of thousands of dollars per year since they must currently absorb the cost of treating these infections. Most importantly, reducing umbilical catheter infection rates would save neonatal lives in any hospital setting. The proposed project will develop a standardized device that reliably secures umbilical cord catheters and protects the catheter insertion site from various sources of infection. The current standard of care for securing these catheters in NICUs across the United States is a roll of non-sterile tape that offers no protective barrier to the catheter insertion site. This is in stark contrast to medical devices that are used with adult catheters and help prevent bloodstream infections. The research objectives include evaluating different materials, testing the catheter securement mechanism, testing bacterial colonization rates, and evaluating the device?s biosafety for use on neonatal skin. This will be accomplished using custom-built testing rigs and protocols. We anticipate the successful development of a device with material specifications that allow for clinical testing in the NICU.