Phase II year
2016
(last award dollars: 2017)
Approximately 10% of all newborns worldwide risk permanent neurotoxic brain injury due severe neonatal jaundice (SNJ). This condition, generally occurring in the first two weeks of life, is almost always cured with high-intensity blue light phototherapy. In the United States, most phototherapy is delivered in a neonatal intensive care unit (NICU) because effective, high-intensity devices have engineering features limiting use to that environment. This current care practice has the undesirable consequence of separating mothers and babies during a developmentally vulnerable time while breastfeeding is being established. Approximately 250,000 otherwise well newborns require phototherapy each year. The annual estimated health care costs for treating SNJ in hospitals are in excess of $300 million. Little Sparrows Technologies has developed the Bili-Hutâ¢, a novel, portable, high-intensity, radial array phototherapy device for use at the mother's bedside in the hospital or in the home. Current phototherapy devices sufficiently portable for home use do not deliver adequate phototherapy to meet the American Academy of Pediatrics recommendations for high-intensity phototherapy. The Bili-Hut⢠meets current phototherapy standards, enables treatment in a mother's post-partum room during birth hospital admission, and eliminates the need for hospital readmissions for otherwise well jaundiced babies who can be treated at home. This will eliminate the stress of separation to the mother-baby pair during treatment at a substantially reduced cost. We have achieved our Phase I goal of creation of a next-stage Bili-Hut⢠that demonstrates efficacy superior to a market-leading NICU phototherapy device through increased skin exposure to therapeutic light. Our Phase II aims will develop capabilities of thermostability and improved infant eye shielding from noxious blue light exposure through an innovative, comprehensive device design. Innovations in this project include the radial Bili-Hut⢠light array with reflective interior, providing superior light distribution, the first environmental temperature-modulated, high-intensity phototherapy device, the first high-intensity phototherapy device to eliminate the need for infant eye protection, and the first mother-baby friendly, high-intensity device that will enable use in the home.
Public Health Relevance Statement: Severe neonatal jaundice is one of the most common conditions resulting in readmissions of newborns. Current care practice requires treatment in a NICU to ensure thermostability while providing high-intensity therapy. This causes stress to families and healthcare costs of >$300K annually. When fully realized, the Bili- Hut⢠will address this public health concern by delivery of portable, high- intensity therapy with thermoregulation capability suitable for use at home.
NIH Spending Category: Bioengineering; Brain Disorders; Chronic Liver Disease and Cirrhosis; Digestive Diseases; Liver Disease; Neurosciences; Patient Safety; Pediatric; Perinatal Period - Conditions Originating in Perinatal Period
Project Terms: Academy; Address; Admission activity; Affect; Amber; American; Area; Attenuated; attenuation; base; Bilirubin; Biological Assay; Birth; Body Surface Area; Brain Injuries; Breast Feeding; Burundi; Caring; Cerebral Palsy; Cessation of life; Clinical; Clinical Trials; cost; Data; Deafness; design; Developed Countries; Developing Countries; Development; Device Approval; Device Designs; Devices; Documentation; Encephalopathies; Engineering; Ensure; Environment; Exposure to; Eye; Family; Feces; field study; Funding; Generations; Goals; Government; Health Care Costs; Health Services Accessibility; Heating; Home environment; Hospital Readmission; Hospitals; Human; Icterus; improved; Incubators; India; Industry; Infant; innovation; Intensive Care Units; Isomerism; Life; Light; Lighting; Low Birth Weight Infant; Marketing; Masks; meetings; meter; Modification; Monitor; Mothers; Neonatal Intensive Care Units; Neonatal Jaundice; neurotoxic; neurotoxicity; Neurotoxins; Newborn Infant; novel; Pathway interactions; Pediatrics; Performance; Phase; Phototherapy; Physiologic Thermoregulation; Positioning Attribute; Postpartum Period; prototype; Public Health; Radial; Recommendation; Research Design; Risk; Rural; Sales; Serum; Skin; Small Business Innovation Research Grant; Sparrows; Staging; Stress; Surface; Technology; Temperature; Testing; Therapeutic; thermostability; Time; tool; Treatment Efficacy; United States; Urine; Visual impairment; Water; Work; World Health Org
