High-intensity, collapsible phototherapy device for neonatal jaundice for home use

家用高强度可折叠新生儿黄疸光疗仪

• 批准号: 8782438
• 负责人: Donna Jean Brezinski
• 金额: $ 14.98万
• 依托单位: LITTLE SPARROWS TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-15 至 2016-02-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8782438
• 关键词: Academy; Address; American; Area; Benchmarking; Bilirubin; Biological Assay; Body Surface Area; Brain Injuries; Breast Feeding; Businesses; Caring; Characteristics; Clinical; Clinical Trials; Clinical Trials Design; Communities; Data; Development; Device Designs; Devices; Dimensions; Engineering; Environment; FDA approved; Family; Funding; Generations; Goals; Grant; Health Care Costs; Hematologist; Home environment; Hospitals; Inpatients; Isomerism; Laboratories; Lead; Life; Light; Lighting; Liver; Manikins; Marketing; Mothers; Neonatal; Neonatal Intensive Care Units; Neonatal Jaundice; Newborn Infant; Nurseries; Optics; Pathway interactions; Patients; Pediatrics; Performance; Phase; Phototherapy; Physiological; Positioning Attribute; Preparation; Process; Property; Public Health; Radial; Recommendation; Relative (related person); Reliance; Risk; Safety; Serum; Shapes; Skin; Small Business Innovation Research Grant; Sparrows; Staging; Stress; Surface; Technology; Testing; Therapeutic Effect; Time; United States; Wallaby; Water; Work; base; comparative; cost; design; experience; hospital readmission; improved; innovation; iterative design; light intensity; meetings; neurotoxic; novel; patient home care; phase 1 study; prevent; prototype; public health relevance; research clinical testing; tool; two-dimensional

DESCRIPTION (provided by applicant): Approximately 8% of all newborns 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) or inpatient nursery because effective, high-intensity devices are designed for 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 cost for treating SNJ in hospitals is in excess of $200 million. Little Sparrows Technologies LLC has developed the Bili-Hut" a novel, collapsible, high-intensity, radial array phototherapy device for home use. Current phototherapy devices sufficiently portable for home use do not deliver adequate phototherapy to meet the current American Academy of Pediatrics recommendations for high intensity phototherapy. Once optimized, the Bili-Hut" will meet current phototherapy standards and eliminate the need hospital readmissions for otherwise well babies. This could significantly reduce the stress to the mother-baby pair during treatment, at a substantially reduced cost. The goal of this proposal is creation of a next-stage Bili-Hut" prototype demonstrating equivalent or superior phototherapy to the market-leading NICU phototherapy device. This will fill an unmet need for an effective home care option. We will achieve this goal by comparing the Bili-Hut" efficacy against that of the Natus neoBlue(R) with a benchmark two-dimensional assay, and a novel-three dimensional baby contour assay that is expected to demonstrate the superiority of radial light delivery in maximizing body surface area exposure. An iterative design process will be influenced by these assay results so that the Bili-Hut's light array, radius of curvature and distance from patient can be optimized for highest possible therapeutic effect. Innovations in this project include a collapsible, radial array, high intensity phototherapy device designed for home use, and a predicted relative efficacy based on a novel baby contour assay. Phase I studies will culminate in a refined prototype to guide industrial design of a device for home treatment of SNJ. Our new assay will provide a theoretical framework for designing clinical trials to test high intensity phototherapy over an increased skin area.

描述（由申请人提供）：大约8%的新生儿由于严重新生儿黄疸（SNJ）有永久性神经毒性脑损伤的风险。这种情况通常发生在生命的前两周，几乎总是用高强度蓝光光疗治愈。在美国，大多数光疗是在新生儿重症监护病房（NICU）或住院托儿所进行的，因为有效的高强度设备是为这种环境设计的。目前这种护理做法的不良后果是，在母乳喂养正在确立的发育脆弱时期将母亲和婴儿分开。每年大约有25万健康的新生儿需要光疗。据估计，每年在医院治疗SNJ的保健费用超过2亿美元。小麻雀技术有限责任公司开发了一种新颖的、可折叠的、高强度的、径向阵列的家用光疗设备Bili-Hut。目前适合家庭使用的便携式光疗设备不能提供足够的光治疗，以满足目前美国儿科学会对高强度光疗的建议。一旦经过优化，“Bili-Hut”将达到目前的光疗法标准，并消除了其他健康婴儿再次住院的需要。这可以大大减少治疗期间母婴对的压力，并大大降低成本。该提案的目标是创建下一阶段的Bili-Hut原型，展示与市场领先的NICU光疗设备相当或更好的光疗。这将填补一个有效的家庭护理选择的未满足需求。我们将通过比较bilii - hut与Natus neoBlue(R)的疗效来实现这一目标，其中包括基准的二维检测，以及一种新的三维婴儿轮廓检测，该检测有望证明径向光传递在最大化体表暴露方面的优势。这些分析结果将影响一个迭代设计过程，以便Bili-Hut的光阵列，曲率半径和与患者的距离可以