Prapela™ SVS: A cost-effective stochastic vibrotactile stimulation device toimprove the clinical course of infants with neonatal abstinence syndrome.

项目总结/文摘

Project Summary/Abstract Maternal use and addiction to opioids has resulted in an unprecedented rise in drug withdrawal complications in newborns, known as neonatal opioid withdrawal syndrome (NOWS), also referred to as neonatal abstinence syndrome (NAS). Between 2004 and 2016, NOWS admissions increased more than fourfold, with an average hospital stay nearly 3.2 times longer (15.9 hospital days compared with 4.98) than for a non-NOWS patient resulting in a surge in annual costs to almost $573 million with 83% attributed to state Medicaid programs (Strahan, 2019). While there is no accepted standard for treating NAS, non-pharmacological bundles are recommended as an initial course of treatment, moving to pharmacological care when required. Unfortunately, non-pharmacological care (swaddling, rocking, frequent feedings, and skin contact) requires significant use of human resources (Theilking, 2017). To reduce the increasing burden on limited resources, the evidence emerges that hospitals are trying to adapt baby products for consumers that were neither intended nor tested for use in NAS infants as part of their non-pharmacological bundle. The objective of this application is to establish the safety, and efficacy of our hospital bassinet pad with stochastic vibrotactile stimulation (SVS) technology as an adjunctive, non-pharmacological treatment to improve the care of infants with NOWS. In Phase I, we demonstrated technical feasibility, replicating the clinically critical stimulation of an investigational device reported to significantly reduce hyperirritability and pathophysiological instabilities without altering sleep states in NOW infants at a cost below $250/unit. We demonstrated the commercial feasibility of introducing the device to 51 healthcare professionals, with over 70% indicating they would use the device as an adjunct to or replace non-pharmacological bundles. During this project, the FDA rejected Prapela’s application for clearance of the SVS hospital bassinet pad with primary concerns of equivalence between a prototype pad used in the clinical study versus the commercial pad and the non-clinical safety of the surface fabric cover material relative to biocompatibility, cleaning and disinfection. To overcome the FDA’s non-clinical safety concerns, we will develop a new pad cover with a new surface fabric material and then pass FDA requirements for biocompatibility, cleaning, and disinfection. To address the FDA concerns of equivalence between the prototype pad and the new commercial pad we will complete in-house vibration studies indicating equivalent performance. The successful completion of the project will provide data for use in a new submission to the FDA for clearance to commercialize our low-cost, non-pharmacological device to improve the clinical course of newborns with NOWS.