SBIR-STTR Award

Neonatal jaundice continues to be a significant global problem affecting 85% of preterm and 15% of term neonates while severe neonatal jaundice affects at least 481,000 neonates annually. Jaundice and jaundice related complications like Kernicterus Spectrum Disorder (KDS) are gaining recognition among the world's health policy leaders as an important area for further research and development. The long-term sequelae of KSD include choreoathetoid cerebral palsy, sensorineural hearing loss, and upward gaze palsy. KSD is irreversible resulting in a lifetime of physical, emotional, social and economic challenges. Access to cost- effective methods of improving pediatric jaundice care along with improved circumferential (full body) illumination technologies is an affirmed objective of the AAP (American Academy of Pediatrics). We hypothesize that unused therapy light (irradiance) surrounding the neonate using an existing single-lamp bank phototherapy device is sufficient in quantity and if redirected onto the patients untreated or poorly illuminated skin surfaces, it will accelerate metabolism and excretion of bilirubin. The product of this STTR application therefore redirects unused phototherapy light sideways onto the neonate body using an open-faced ring approach. The technology will illuminate previously unexposed and poorly exposed skin regions where treatable bilirubin exists. A transparent inner guard protects the neonate's head from rolling on the light- reflective surfaces. Preliminary data support the validity of our approach. The device is superior to current PT devices in that it converts existing waste light into treatment efficacy while integrating into existing overhead lamp systems offsetting the purchase of secondary devices that are often expensive and create hospital complexity, cost and inefficiency issues. A further benefit of the device will be reduced ambient blue-light spillover in patient care areas, an ongoing concern for medical staff. The Phase I Specific Aims are to (SA1) construct a clinically testable prototype and (SA2) conduct a clinical trial on 75 neonates to establish safety and efficacy. The Phase II objective will be a randomized superiority trial study which will also demonstrate reduced hospitalization time, early parent-bonding and breast-feeding initiation. A survey of responding pediatricians indicated >95% had a strong willingness to adopt the proposed device with proof of safety and efficacy.

Public Health Relevance Statement:
PROJECT NARRATIVE In this STTR Phase I, Arbor Grace will further the development of our patent-pending neonatal jaundice treatment accelerator using circumferential redirection of unused phototherapy light onto an infants untreated skin surfaces. The redirected light will cost-effectively accelerate the treatment of jaundice thereby protecting the infant from irreversible KSD (brain damage by yellow staining) that results from poorly treated pediatric jaundice. The solution will provide improved standards of care in high, middle, and low-income regions.

Project Terms:
Academy; Acceleration; Address; Adopted; Advanced Development; Affect; American; Apnea; Area; Bilirubin; Bradycardia; Brain Injuries; Breast Feeding; Businesses; Caring; Cerebral Palsy; Chest; Child; Childhood; Clinical; Clinical Trials; Community Hospitals; cost; cost effective; Data; Development; Devices; Dimensions; Disease; Economically Deprived Population; Economics; efficacy research; Emotional; Excretory function; experience; falls; Female; Fiber Optics; Foundations; gaze palsy; Goals; Growth; Growth and Development function; Head; Health Care Research; Health Policy; hospital readmission; Hospitalization; Hospitals; Hour; Icterus; Impairment; improved; improved outcome; Infant; infant outcome; Kernicterus; Lead; Legal patent; Length of Stay; Light; Lighting; Low income; Maintenance; male; Measurable; Measures; Medical; Medical Device; Medical Staff; Metabolism; Methods; Minnesota; Neonatal Jaundice; neonate; Netherlands; neurotoxic; off-patent; Outcome; Parents; Patient Care; Patients; pediatrician; Pediatrics; Phase; Phototherapy; Pilot Projects; Premature Infant; prototype; Publishing; Randomized; Randomized Controlled Trials; Research; research and development; Research Institute; response; Safety; Sensorineural Hearing Loss; Serum; side effect; Skin; Small Business Technology Transfer Research; social; socioeconomics; Stains; standard of care; Surface; Surveys; System; Technology; Temperature; Time; Treatment Efficacy; trial comparing; UNICEF; Universities; wasting; Weight; willingness; World Health