Phase I SBIR proposals will be accepted. Fast-Track proposals will not be accepted. Phase I clinical trials will be accepted. Number of anticipated awards: 1 Budget (total costs): Phase I: up to $150,000 for up to 6 months PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Background Reflective of the larger opioid epidemic, the number of newborns dependent on opioids has increased dramatically, from 2,920 in 2000 to 31,904 in 2014, the latest year of published data. These newborns experience withdrawal symptoms after birth, which can include: high-pitched and excessive crying, increased muscle tone, uncontrollable shaking (tremors), sweating or fever, rapid breathing rate, frequent yawning, and poor feeding and growth. Newborns born dependent to opioids have longer birth hospitalizations (17 days versus 2 days mean length of stay for a healthy newborn) and higher hospitalization costs ($19,340 versus $3,700 for a healthy newborn). Assessment of withdrawal symptoms depends on the judgement and experience of clinical staff, which may vary and can result in inadequate treatment. For example, assessment of a high-pitch and excessive cry can vary between nurses. Different observations can result in incorrect treatment. Additionally, it may be difficult for staff to distinguish whether observed symptoms are due to withdrawal or simply waking a sleeping newborn at set times. Using technology to standardize symptom measurement would reduce variation in diagnosis and quality of care; however, no such device exists. Creating a device that objectively measures withdrawal symptoms in a continuous manner could greatly improve the care of these newborns. Project Goals The goal of this project is to create a wearable device that objectively measures a newborn’s withdrawal symptoms, including: 1. tremors (frequency and duration, start and stop time); 2. muscle tone (degree of rigidity); 3. crying (frequency, duration, pitch); 4. body temperature (fluctuations); and, 5. sleep (duration, frequency of sleep cycles). The device will have the following characteristics: 1. small and unnoticeable for newborn wear; 2. humidity-resistant; 3. bacteria-resistant (infection-controlled); 4. single use; 5. wireless; 6. able to capture data for 12-hours without interruption; and, 7. user-friendly interface for clinicians to view symptoms. Phase I Activities and Expected Deliverables The expected deliverable for Phase I is a functional prototype with the above mentioned specifications. Wearable technology is capable of capturing body temperature, movement, and sleep cycles for adults. It is anticipated that this technology could be adapted or developed for newborns. Activities for Phase I include: 1. Build upon existing technology to create a device that not only captures body temperature, movement, and sleep, but also sound (crying frequency, duration, pitch) and muscle tone (degree of rigidity); 2. Ensure the device is small enough and safe for newborn wear; 3. Create a user-friendly interface to view symptoms and guide diagnosis, treatment, and management of opioid withdrawal in newborns. Impact The number of newborns with opioid withdrawal has increased dramatically from only 2,920 newborns in 2000 to 31,904 newborns in 2014. In 2011-2014, newborns with opioid withdrawal cost Medicaid$462 million. A device that assists clinicians in accurate assessment of withdrawal symptoms in newborns could lead to improved diagnosis and management along with shorter lengths of stay (and lower costs). Exposure to medication-assisted treatment can also lead to newborns with opioid withdrawal. Initiatives to improve the care of these newborns, supplemented by devices that can objectively monitor symptoms, is key to improving quality and standards of care. To be successful, the awardee will have to demonstrate ability to design a safe, functional device (as described above) and navigate Institutional Review Board approval for any potential clinical research or requirements necessary for FDA approval. Compliance requirements for FDA approval may vary depending on how the device is developed. Commercialization Potential This technology could greatly improve the diagnosis and management of newborns with opioid withdrawal in hospitals and neonatal intensive care units. In 2014, over 31,904 U.S. newborns had opioid withdrawal and stayed an average of 15 days in the hospital longer than newborns without withdrawal. Estimates of newborns with opioid withdrawal are expected to increase with the ongoing opioid epidemic. This technology could be used across the U.S. in all hospitals and neonatal intensive care units that care for newborns with withdrawal.