Prapela, Inc. SBIR Phase I Award, April 2019

Project Summary Abstract Maternal use and addiction to opioids or other drugs has resulted in an unprecedented rise in drug withdrawal complications in newborns known as neonatal abstinence syndromeNASBetweenandNAS admissions increased more than fourfold with an average hospital stay nearlytimes longerhospital days compared withpandltfor a non NAS patientCorrand a sixfold increase in NICU days attributable to NASToliaresulting in a surge in annual costs to nearly $millionCorrand aggregate hospital charges of $billion withattributed to state Medicaid programsPatrick SWWhile there is no accepted standard for treating NASnon pharmacological bundles are recommended as an initial course of treatmentUnfortunatelynon pharmacological careswaddlingrockingfrequent feedings and skin contactrequire significant use of human resourcesTheilkingTo reduce the increasing burden on limited resourcesthe evidence emerges that hospitals are trying to adapt the baby products for consumer mass market that were neither intended nor tested for use in NAS infants as part of their non pharmacological bundleThe objective of this application is to establish the technical and commercial feasibility of our stochastic vibrotactile stimulationSVStechnology incorporated into the hospital bassinet padIn peer reviewed studiesthe novelgentlerandom vibration produced by the versionSVS investigational device significantly improved relaxation and increased eupneic breaths and eucardic heart beats of NAS babiesZuzarte Iwithout altering infant sleep stateshowever innovation is required to develop this productTo accomplish the objectivewe plan to execute the following specific aimsdemonstrate the technical feasibility of the SVS hospital bassinet pad anddemonstrate the commercial feasibility and merit of the SVS hospital bassinet pad with healthcare professionals responsible for treating infants with NASTechnical feasibility will be established through the development of specificationscreating prototypes as well as bench testing to the specifications of a minimum viable product prototypeInnovation is required to produce an easy to usecost effectivemanufacturing scalable product that replicates the same vibration characteristics in the proven investigational deviceversionCommercial feasibility will be demonstrated by confirming with nurses and physicians with user testing research that the device would change their behaviors and could be used as an adjunct to or replace non pharmacological bundles which treat NAS babiesThe successful completion of the project will validate the SVS hospital bassinet pad as cost effective medical device to improve the clinical course of infants with neonatal abstinence syndromeSuccess will also move us closer to our long term goal of providing a proven medical device to help maximize short and long term outcomes while reducing annual costs NARRATIVE The project will demonstrate the technical and commercial feasibility of converting a clinically tested technology into a medical device for use in the hospital to improve the clinical course of infants with neonatal abstinence syndromeNASa postnatal drug withdrawal syndrome occurring in opioid exposed newbornsIf successfulthe product will provide a complementary non pharmacological treatment reducing the burden on caregiversfamilies and others who care and pay for the cost to treat neonatal abstinence syndrome infantsA long term goal of our work is to introduce a non pharmacological NAS device that maximizes short and long term outcomes while minimizing costs