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 syndrome (NAS). Between 2003 and 2012, NAS admissions increased more than fourfold with an average hospital stay nearly 3.5 times longer (16.57 hospital days compared with 4.98, p< 0.001) for a non-NAS patient (Corr, 2017) and a sixfold increase in NICU days attributable to NAS (Tolia, 2015) resulting in a surge in annual costs to nearly $316 million (Corr, 2017) and aggregate hospital charges of $1.5 billion with 81% attributed to state Medicaid programs (Patrick SW, 2015). While there is no accepted standard for treating NAS, non-pharmacological bundles are recommended as an initial course of treatment. Unfortunately, non-pharmacological care (swaddling, rocking, frequent feedings and skin contact) require significant use of human resources (Theilking, 2017). To reduce the increasing burden on limited resources, the 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 bundle. The objective of this application is to establish the technical and commercial feasibility of our stochastic vibrotactile stimulation (SVS) technology incorporated into the hospital bassinet pad. In peer-reviewed studies, the novel, gentle, random vibration produced by the version 1.0 SVS investigational device significantly improved relaxation and increased eupneic breaths and eucardic heart beats of NAS babies (Zuzarte I., 2017) without altering infant sleep states, however innovation is required to develop this product. To accomplish the objective, we plan to execute the following specific aims; 1) demonstrate the technical feasibility of the SVS hospital bassinet pad and 2) demonstrate the commercial feasibility and merit of the SVS hospital bassinet pad with healthcare professionals responsible for treating infants with NAS. Technical feasibility will be established through the development of specifications, creating prototypes as well as bench testing to the specifications of a minimum viable product prototype. Innovation is required to produce an easy to use, cost-effective, manufacturing scalable product that replicates the same vibration characteristics in the proven investigational device (version 1.0). Commercial 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 babies. The 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 syndrome. Success 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 syndrome (NAS), a postnatal drug withdrawal syndrome occurring in opioid exposed newborns. If successful, the product will provide a complementary non-pharmacological treatment reducing the burden on caregivers, families and others who care and pay for the cost to treat neonatal abstinence syndrome infants. A long-term goal of our work is to introduce a non-pharmacological NAS device that maximizes short and long-term outcomes while minimizing costs.