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

描述（由申请人提供）：大约8%的新生儿因严重新生儿黄疸（SNJ）而面临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室（NICU）或住院托儿所进行的，因为有效的高强度设备是为该环境设计的。目前的这种护理做法产生了不良后果，即在母乳喂养期间，在发育脆弱的时期将母亲和婴儿分开。每年大约有25万名新生儿需要光疗。每年在医院治疗SNJ的估计医疗费用超过2亿美元。小麻雀技术有限责任公司开发了比利小屋”一种新颖的，可折叠的，高强度，放射状阵列光疗设备的家庭使用。目前的光疗设备对于家庭使用来说足够便携，但不能提供足够的光疗来满足目前美国儿科学会对高强度光疗的建议。一旦优化，Bili-Hut”将符合目前的光疗标准，并消除了其他健康婴儿再次入院的需要。这可以大大减少治疗期间对母婴的压力，同时大幅降低成本。本提案的目标是创建下一阶段Bili-Hut”原型，以证明与市场领先的NICU光疗设备等同或上级光疗。这将填补一个有效的家庭护理选择未满足的需求。我们将通过比较Bili-Hut与Natus neoBlue（R）的功效来实现这一目标，该功效具有基准二维测定和新型三维婴儿轮廓测定，预计该测定将证明径向光递送在最大化体表面积暴露方面的优越性。迭代设计过程将受到这些测定结果的影响，使得Bili-Hut的光阵列、曲率半径和与患者的距离可以 以获得最佳的治疗效果。在这个项目中的创新包括一个可折叠的，放射状阵列，高强度光疗设备设计用于家庭使用，和一个预测的相对疗效的基础上，一个新的婴儿轮廓测定。第一阶段的研究将最终在一个完善的原型，以指导工业设计的设备，家庭治疗SNJ。我们的新检测方法将为设计临床试验提供理论框架，以在增加的皮肤面积上测试高强度光疗。

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.