Point-of-Care System for Determination of Bilirubin Capacity in Neonates

用于测定新生儿胆红素容量的护理点系统

• 批准号: 9141256
• 负责人: VINOD K BHUTANI
• 金额: $ 98.4万
• 依托单位: AVIV BIOMEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-01 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9141256
• 关键词: Albumins; Ambulatory Care Facilities; Bar Codes; Benign; Bilirubin; Binding; Biological Assay; Calibration; Clinical; Clinical Management; Clinical Research; Communities; Computer software; Consult; Data; Deposition; Development; Device Designs; Devices; Documentation; Environment; Error Sources; Evaluation; Glass; Goals; Grant; Hemoglobin; Hospitals; Humidity; Hyperbilirubinemia; Infant; Information Management; Kernicterus; Knowledge; Laboratories; Life; Light; Management Information Systems; Manuals; Marketing; Measurement; Measures; Medical; Metabolic; Methods; Modification; Molecular; Monitor; Neonatal; Neonatal Intensive Care Units; Neonatal Jaundice; Neuraxis; Neurologic Dysfunctions; Newborn Infant; Nurseries; Optics; Pediatric Hospitals; Performance; Phase; Plasma; Plasma Proteins; Point-of-Care Systems; Positioning Attribute; Premature Infant; Publishing; Reader; Reagent; Recommendation; Risk; Sales; Sampling; Serum Albumin; Signal Transduction; Slide; Small Business Innovation Research Grant; Surveys; System; Temperature; Testing; Tube; Universities; Validation; Work; base; caregiving; commercialization; coping; design; experience; improved; instrument; neonatal care; neonate; neurotoxicity; operation; point of care; prevent; public health relevance

 DESCRIPTION (provided by applicant): Neonatal hyperbilirubinemia occurs in almost all newborns, and may be benign if its progression to extreme hyperbilirubinemia is recognized, monitored, and prevented or managed in a timely manner. Neonatal jaundice carries the risk of neurotoxicity, due to the deposition of bilirubin in the central nervous system. Most of the bilirubin in plasma is bound to plasma proteins (mainly serum albumin). Bilirubin binding capacity (BBC) defines the dynamic relationship between an infant's level of unbound or "free" bilirubin and his/her ability to "tolerate" increasing bilirubin loads. BBC is not synonymous with albumin (Alb) levels because Alb binding of bilirubin is confounded by a variety of molecular, biologic, and metabolic factors. While various methods exist to measure BBC, none have been successfully commercialized. Of these, hematofluorometry holds the greatest promise of a device that can be used at the point of care, and give rapid and accurate BBC measurements. A SBIR Phase I grant demonstrated that such a device is possible. A Phase II grant delivered improved devices to neonatal hospitals. Published clinical studies with these devices not only collaborated prior knowledge, but suggested ways in which BBC measurements may improve existing neonatal care. The aims of this project are to transform the modernized hematofluorometers developed in Phases I and II into a final product suitable for operation in a point-of-care environment in the newborn nursery, NICU, and neonatal outpatient clinic. In year one, Aviv's goals are to develop and evaluate a "single" position hematofluorometer in terms of increased accuracy over prior designs; develop and evaluate kit designs that increase the ease of use; improve the use of the internal reference; develop primary standards for calibration; develop validation checks. Beginning in year 1 and continuing into year 2, Aviv will: perform shelf-life tests; determine environmental limits of operation; integrate a bar code reader and laboratory information management software support; internal quality checks into the device and software; investigate potential interferences to measurements; and incorporate guidance for use into documentation and software. During year 2 Aviv will: have a commercializable embodiment; develop methods and documentation; identify partners for manufacturing, marketing, sales, and distribution. Concurrent with these activities, Stanford University's Lucile Packard Children's Hospital will conduct clinical studies to evaluate the usefulness of BBC measurements in a clinical setting. Experienced consultants in the fields of neonatal care management, clinical lab directors, and those with hands-on experience neonatal intensive care units and clinical labs will be consulted on the suitability of the device and reagent kit. The goal is to obtain expert recommendations for the use of the BBC assay to inform additional clinically useful modifications of the hematofluorometer system.

 描述（由适用提供）：新生儿高脂蛋白血症几乎在所有新生儿中都会发生，如果及时地识别，监测和预防或管理，则可能会良性。由于胆红素在中枢神经系统中的沉积，新生儿黄疸具有神经毒性的风险。血浆中的大多数胆红素与血浆蛋白（主要是血清白蛋白）结合。胆红素结合能力（BBC）定义了婴儿未结合或“自由”胆红素水平与他/她“耐受”增加胆红素载荷的能力之间的动态关系。 BBC与专辑（ALB）水平没有合成，因为胆红素的ALB结合被各种分子，生物学和代谢因子混淆。尽管存在各种衡量BBC的方法，但没有成功商业化。其中，血荧光测定法具有可以在护理点使用的设备的最大诺言，并进行快速准确的BBC测量。 SBIR阶段的授予证明了这种设备是可能的。 II期赠款将改进的设备提供给新生儿医院。使用这些设备发表的临床研究不仅合作了先验知识，而且建议BBC测量可以改善现有新生儿护理的方法。该项目的目的是将在第I和II阶段开发的现代化血荧光仪变为最终产品，适合在新生儿托儿所，NICU和新生儿门诊诊所的护理点环境中运行。在第一年，Aviv的目标是根据先前设计的准确性提高，开发和评估“单一”位置血压计；开发和评估套件设计，以提高使用易用性；改善内部参考的使用；制定校准的主要标准；开发验证检查。从第一年开始，一直持续到第二年，Aviv将：进行货架寿命测试；确定操作的环境极限；集成了条形码阅读器和实验室信息管理软件支持；内部质量检查设备和软件；研究与测量值的潜在接口；并将使用指南纳入文档和软件中。在第二年，Aviv将：有一个可商业化的体现；开发的方法和文档；确定用于制造，营销，销售和分销的合作伙伴。同时，斯坦福大学的Lucile Packard儿童医院将进行临床研究，以评估BBC测量在临床环境中的有用性。新生儿护理管理，临床实验室主管以及具有动手经验的新生儿重症监护病房和临床实验室的经验丰富的顾问将就设备和试剂套件的适用性进行咨询。目的是获得使用BBC测定法的专家建议，以告知血液荧光仪系统的其他临床有用修改。