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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要新生儿的肝功能不成熟，代谢胆红素的效率低下。因此，近 80% 早产儿和 60% 的足月儿在出生一周内会出现高胆红素血症，导致新生儿黄疸他们的诞生。由于严重的高胆红素血症可能致命，因此早期、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。检测的黄金标准高胆红素血症是一种侵入性血液检测，用于测量血清总胆红素 (TSB)；但经常抽血对新生儿进行采样不仅成本高昂、痛苦，而且会增加感染的机会。现有的非侵入性方法监测高胆红素血症缺乏足够的准确性来替代血液检测。尽管商业化的经皮胆红素测定（TcB）是临床上公认的黄疸筛查方法，与临床上的 TSB 相关性较低。黑皮肤新生儿的决策能力，并且在低/中等收入国家 (LMIC) 的可用性较低。 TcB 限制的一个主要原因是光谱串扰：无法可靠地区分皮肤分析物（即黑色素）和血液之间的贡献。我们的中心假设是非侵入性可以开发基于手机的胆红素检测仪，提供准确的护理点血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），一种具有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，用于无创、深度分辨血液测量光谱。我们的工作假设是，胆红素的深度分辨 sOCT 光谱与全血样本的光谱数据。我们的创新技术设计将实现小型化和集成化将传统的 SOCT 组件集成到紧凑的智能手机附件中。我们还将开发智能手机应用程序执行数据处理、分析、显示和符合 HIPAA 标准的传输或存储一台笨重的计算机。在目标 2 中，我们将在体内完善和测试 sOCT 算法。我们的工作假设是与各种皮肤的临床 TcB 相比，sOCT 测量与实验室 TSB 的相关性更好音调。在一项针对 100 名新生儿的临床研究中，我们将 sOCT 数据与 TSB 血液测试和商业测试数据进行比较 TCB。在目标 3 中，我们将验证 sOCT 在尼日利亚卡诺的深色皮肤新生儿中的性能。我们的工作假设是，SOCT 在深色皮肤新生儿中的表现与基于实验室的 TSB 测试相当，并且可接受在 LMIC 设置中使用。我们还将评估将 sOCT 纳入中低收入国家医院的临床工作流程。如果成功，sOCT 可以提供商业化的准确替代方案 TcB 涵盖多种肤色，包括深色皮肤的新生儿，可能会取代侵入性方法检测和监测中低收入国家的高胆红素血症。