SBIR-STTR Award

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.

Public Health Relevance Statement:
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.

Project Terms:
Academy; Behavior; Budgets; Systematics; Classification; drug/agent; Pharmaceutic Preparations; Medication; Drugs; Pharmaceutical Preparations; balance function; balance; Equilibrium; Family; Goals; Grant; Heart; Hospitals; Modern Man; Human; Infant; newborn children; newborn child; Newborns; 0-4 weeks old; Newborn Infant; Knee; hospital stay; hospital length of stay; hospital days; Number of Days in Hospital; Length of Stay; Marketing; Medicaid; Medical Device; Methods; National Institutes of Health; NIH; United States National Institutes of Health; Neonatal Withdrawal Syndrome; Neonatal Substance Withdrawal; Neonatal Opioid Withdrawal Syndrome; Neonatal Abstinence Syndrome; nurse; Nurses; Patients; Pediatrics; Peer Review; Physicians; Relaxation; Research; R&D; R & D; Development and Research; research and development; Research Resources; Resources; Shoes; Withdrawal Syndrome; Substance Withdrawal Syndrome; Supervision; Survey Instrument; Surveys; Technology; Testing; Time; Work; Research Subjects; Care Givers; Caregivers; Caring; drug withdrawal; base; improved; Clinical; Phase; Hospital Sizes; Hospital Charges; Opioid; Opiates; Policies; Supportive care; Supportive Therapy; programs; Investigation; postnatal; vibration; meetings; American; consumer product; Performance; success; novel; treatment program; Devices; Human Resources; personnel; Manpower; Touch sensation; tactile sensation; Touch; Admission activity; Admission; Skin; preventing; prevent; Address; Applications Grants; Grant Proposals; Regulatory Pathway; Small Business Innovation Research Grant; Small Business Innovation Research; SBIR; Characteristics; Process; Development; developmental; Health Professional; Healthcare professional; Health Care Professional; Output; cost; feeding; design; designing; Infant sleep state; Outcome; cost effective; Consumption; innovation; innovative; innovate; clinically relevant; clinical relevance; usability; volunteer; addiction; addictive disorder; prototype; opioid use disorder; opiate use disorder; nursing mothers; opioid exposure; opioid exposed; opiate exposure; opiate exposed; preservation; vibrotactile stimulation

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) 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 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, efficacy, and acceptability 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 one, 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 commercial feasibility 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. To accomplish the objective, we plan to execute the following specific aims; 1) determine the efficacy of the SVS hospital bassinet pad, 2) demonstrate the safety of the SVS hospital bassinet pad, and 3) assess acceptability of the device with clinical staff and parents caring for infants with NOWS. Efficacy will be established through a clinical study with NOWS infants who have reached severity criteria for pharmacological treatment using the modified Finnegan scoring method. Cardio-respiratory monitoring will capture measurements allowing comparison of periods when SVS is on or off. With each infant serving as its own control, the primary outcome measure will be the stability of cardiorespiratory control. In addition to non- clinical product testing, safety will be demonstrated by scoring sleep state durations with a masked trained reviewer of high-resolution video recordings. A change of 20% in the duration of quiet sleep when SVS is on compared to off will be considered significant. Acceptability will be assessed with interviews completed by clinical staff and parents measuring their perceptions on ease of use, infant comfort, and interest in future use of the device. The successful completion of the project will provide data to support FDA clearance for commercialization of our low-cost, non-pharmacological device to improve the clinical course of newborns with NOWS.

Public Health Relevance Statement:
NARRATIVE The project will establish the safety, efficacy, and acceptability of our SVS hospital bassinet pad as a low-cost medical device for use in the hospital to improve the clinical course of newborns with neonatal opioid withdrawal syndrome (NOWS). Infants diagnosed with NOWS experience difficult symptoms, including excessive crying, irritability, rapid breathing, and heart rates, tremors, and sometimes seizures. If successful, the device will provide a complementary non-pharmacological treatment improving outcomes while reducing the burden on caregivers, families, and others who care and pay for the cost to treat neonatal opioid withdrawal syndrome infants.

Project Terms:
drug withdrawal; base; Perinatal; Peripartum; improved; Acute; Clinical; Phase; Coronavirus; Coronaviridae; corona virus; Training; Opioid; Opiates; Measurement; programs; Investigation; Hour; Severities; Protocol; Protocols documentation; interest; American; biocompatibility; biomaterial compatibility; consumer product; experience; Devices; Manpower; personnel; Human Resources; Reporting; Admission; Admission activity; Sleep Wake Cycle; Skin; Symptoms; Data; NIDA; National Institute on Drug Abuse; National Institute of Drug Abuse; Resolution; Pharmacological Treatment; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Monitor; Health Professional; Health Care Professional; Healthcare professional; cost; Outcome; cost effective; innovation; innovate; innovative; addiction; addictive disorder; commercialization; pregnant; primary outcome; efficacy testing; public health emergency; neonatal care; opioid use disorder; opiate use disorder; improved outcome; opioid epidemic; opiate crisis; opioid crisis; preservation; morphine equivalent; morphine equivalence; vibrotactile stimulation; Home; Academy; Breathing; Respiratory Aspiration; Respiratory Inspiration; inspiration; Birth; Parturition; Clinical Research; Clinical Study; Crying; Diagnosis; Disadvantaged; Electromagnetics; Epidemic; Family; Future; Grant; Heart Rate; Cardiac Chronotropism; Hospitalization; Hospital Admission; Hospitals; Human; Modern Man; Incidence; Infant; Infant Care; baby care; infant health care; infant healthcare; newborn care; Newborn Infant; 0-4 weeks old; Newborns; newborn child; newborn children; Interview; Kentucky; Length of Stay; Number of Days in Hospital; hospital days; hospital length of stay; hospital stay; Light; Photoradiation; Marketing; Masks; Mattresses; Medicaid; Medical Device; men; men's; Methods; Neonatal Abstinence Syndrome; Neonatal Opioid Withdrawal Syndrome; Neonatal Substance Withdrawal; Neonatal Withdrawal Syndrome; newborn abstinence syndrome; Discipline of Nursing; Nursing; Nursing Field; Nursing Profession; Ohio; Overdose; Parents; Patients; Pediatrics; Perception; Pharmacology; Pregnancy; Gestation; Research; Resources; Research Resources; Safety; Scoring Method; Seizures; Sleep; Sleep disturbances; aberrant sleep; disrupted sleep; disturbed sleep; impaired sleep; irregular sleep; sleep disruption; sleep dysregulation; sound; Technology; Temperature; Testing; Time; Tremor; Video Recording; Videorecording; video recording system; Woman; Work; Measures; Caregivers; Care Givers; Medical Care Costs; medical costs; Outcome Measure; Caring