Smart-phone-integrated, non-invasive, depth-resolved optical spectroscopy for the detection of neonatal jaundice

用于检测新生儿黄疸的智能手机集成、非侵入性、深度分辨光谱

• 批准号: 10677538
• 负责人: Audrey Kynsella Bowden
• 金额: $ 40.42万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-08 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10677538
• 关键词: Acute; African; Agreement; Algorithms; Bilirubin; Birth; Blood; Blood Tests; Blood Vessels; Blood specimen; Cause of Death; Cellular Phone; Chest; Clinical; Clinical Research; Computers; Darkness; Data; Detection; Developing Countries; Devices; Forehead; Frequencies; Health; Health Insurance Portability and Accountability Act; Heel; Hemoglobin; Hospitals; Hour; Hyperbilirubinemia; Icterus; Imaging Techniques; Infection; Kernicterus; Laboratories; Measurement; Measures; Melanins; Methods; Miniaturization; Monitor; Morbidity - disease rate; Neonatal Jaundice; Neonatology; Newborn Infant; Nigeria; Noise; Optical Coherence Tomography; Optics; Pain; Patients; Performance; Photography; Phototherapy; Point of Care Technology; Resolution; Serum; Signal Transduction; Skin; Spectrum Analysis; Structure; System; Teaching Hospitals; Technology; Testing; Time; Tissues; Transfusion; Variant; Whole Blood; Work; clinical decision-making; clinically relevant; computerized data processing; cost; design; detector; experience; global health; in vivo; innovation; liver function; low and middle-income countries; low income country; mHealth; miniaturize; mobile application; mortality; neonatal death; neonate; novel; peripheral blood vessel; point of care; point-of-care detection; portability; screening; smartphone application; statistics; transmission process

PROJECT SUMMARY Newborns have immature liver function that is inefficient at metabolizing bilirubin. Consequently, nearly 80% of preterm and 60% of term babies develop hyperbilirubinemia resulting in neonatal jaundice within a week of their birth. As severe hyperbilirubinemia can be fatal, early, frequent and accurate monitoring of bilirubin is vital to avoid severe health issues and determine appropriate treatment. The gold standard for detecting hyperbilirubinemia is an invasive blood test to measure total serum bilirubin (TSB); however, frequent blood sampling in neonates is costly, painful and increases the chance of infection. Existing non-invasive methods to monitor hyperbilirubinemia lack sufficient accuracy to replace blood tests. Although commercial transcutaneous bilirubinometry (TcB) is clinically accepted for jaundice screening, it has low correlation with TSB for clinical decision-making in dark-skinned neonates and has low availability in low/middle income countries (LMICs). A main reason for the limitation of TcB is spectral cross-talk: the inability to reliably distinguish contributions between skin analytes (i.e., melanin) and blood. Our central hypothesis is that a non-invasive mobile phone-based bilirubin detector can be developed that provides accurate, point-of-care blood bilirubin measurements in dark-skinned neonates. We propose to use spectroscopic optical coherence tomography (sOCT), an imaging technique those depth-resolved capabilities can overcome spectral cross-talk. In Aim 1 we will develop portable, mobile phone-integrated sOCT for non-invasive, depth-resolved measurement of blood spectra. Our working hypothesis is that depth-resolved, sOCT spectra of bilirubin correlate strongly with spectral data from whole blood samples. Our innovative technical design will miniaturize and integrate traditional sOCT components into a compact smartphone attachment. We will also develop a smartphone application to perform data processing, analysis, display and HIPAA-compliant transmission or storage in lieu of a bulky computer. In Aim 2 we will refine and test the sOCT algorithm in vivo. Our working hypothesis is that sOCT measurements correlate better with lab-based TSB than does clinical TcB across a diverse range of skin tones. In a clinical study of 100 neonates, we will compare sOCT data to the TSB blood tests and commercial TcB. In Aim 3 we will validate the performance of sOCT in dark-skinned neonates from Kano, Nigeria. Our working hypothesis is that sOCT performs comparably to lab-based TSB tests in dark-skinned neonates and is acceptable for use in a LMIC setting. We will also assess potential challenges to incorporating sOCT into the clinical workflow of a LMIC hospital. If successful, sOCT can provide an accurate alternative to commercial TcB across diverse skin tones, including dark-skinned neonates and may potentially replace invasive methods to detect and monitor hyperbilirubinemia in LMICs.

项目摘要 新生儿具有未成熟的肝功能，在代谢胆红素方面效率低下。因此，将近80％ 早产和60％的婴儿患有高胆红素血症，导致新生儿黄疸在一周内 他们的出生。由于严重的高胆红素血症可能是致命的，早期，频繁和准确的胆红素监测至关重要 避免严重的健康问题并确定适当的治疗方法。检测金标准 高胆红素血症是一种侵入性血液检查，用于测量总血清胆红素（TSB）；但是，频繁的血液 新生儿的采样是昂贵，痛苦的，并增加了感染的机会。现有的非侵入性方法 监测高胆红素血症缺乏足够的精度来替代血液检查。虽然是经常的经牙 胆红素法（TCB）在临床上接受黄疸筛查，与TSB的相关性较低 深色皮肤新生儿的决策，低/中收入国家（LMIC）的可用性较低。 TCB限制的主要原因是光谱串扰：无法可靠区分 皮肤分析（即黑色素）和血液之间的贡献。我们的中心假设是无创的 可以开发基于手机的胆红素探测器，可提供准确的护理血液胆红素 深色皮肤新生儿的测量。我们建议使用光谱光学相干断层扫描 （SOCT），这些深度分辨能力的成像技术可以克服光谱串扰。在目标1中我们 将开发便携式，手机集成的SOCT，以进行非侵入性，深度分辨的血液测量 光谱。我们的工作假设是胆红素的深度分辨，SOCT光谱与 来自全血样品的光谱数据。我们的创新技术设计将微型化和整合 传统的SOCT组件成紧凑的智能手机附件。我们还将开发智能手机 应用数据处理，分析，显示和符合HIPAA的传输或存储 一台笨重的计算机。在AIM 2中，我们将在体内完善并测试SOCT算法。我们工作的假设是 与临床TCB相比，SOCT测量与基于实验室的TSB更好 音调。在100个新生儿的临床研究中，我们将SOCT数据与TSB血液测试和商业 TCB。在AIM 3中，我们将验证来自尼日利亚卡诺的深色皮肤新生儿SOCT的表现。我们的 工作假设是SOCT与深色皮肤新生儿中的基于实验室的TSB测试相当 可以在LMIC设置中使用。我们还将评估将SOCT纳入其中的潜在挑战 LMIC医院的临床工作流程。如果成功，SOCT可以为商业提供准确的替代品 TCB跨越不同的肤色，包括深色皮肤新生儿，并可能取代侵入性方法 在LMIC中检测和监测高胆红素血症。