Advancing Fetal Assessment during Labor with Transabdominal Fetal Oximetry

通过经腹胎儿血氧测定法推进分娩过程中的胎儿评估

• 批准号: 10602292
• 负责人: Neil Padharia Ray
• 金额: $ 85.57万
• 依托单位: RAYDIANT OXIMETRY, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-15 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10602292
• 关键词: 3-Dimensional; Abdomen; Advanced Development; Agreement; Algorithms; Award; Calibration; Cardiotocography; Cesarean section; Clinical; Clinical Research; Collection; Communities; Computational algorithm; Computer Models; Computer Simulation; Confidence Intervals; Data; Data Set; Detection; Development; Devices; Electronics; Emergency Situation; Fetal Distress; Fetal Heart Rate; Fetal Monitoring; Fetal Reduction; Fetus; Future; Goals; Health Care Costs; Hospitals; Human; Hypoxemia; Hypoxia; Institutional Review Boards; Label; Legal patent; Machine Learning; Marketing; Measurement; Medical; Metabolic acidosis; Methods; Modality; Modeling; Monitor; Morbidity - disease rate; Mothers; National Institute of Child Health and Human Development; Neonatal; Newborn Infant; Optics; Outcome; Output; Oxygen; Oxygen saturation measurement; Performance; Phase; Physiologic Monitoring; Physiologic pulse; Pregnant Women; Pregnant sheep; Protocols documentation; Pulse Oximetry; Reporting; Research; Risk; Sensitivity and Specificity; Sheep; Signal Transduction; Small Business Innovation Research Grant; Specificity; System; Techniques; Technology; Tissues; Training; Update; Uterine Contraction; Validation; adverse outcome; algorithm development; commercialization; computerized data processing; deprivation; design; ewe model; fetal; fetal blood; fetal diagnosis; fetus at risk; fetus hypoxia; first-in-human; heart rate monitor; human data; human subject; improved; in utero; in vivo; interest; intrapartum; machine learning model; mortality; neonatal hypoxic-ischemic brain injury; neonatal outcome; network architecture; non-invasive monitor; novel; pre-clinical; preclinical study; response; sensor technology; transfer learning; virtual

Project Abstract Raydiant Oximetry, Inc. (Raydiant) has developed and patented a novel optical-sensing technology (‘LumerahTM’) to directly assess fetal status during labor and delivery through non-invasive, transabdominal measurement of fetal oxygenation. This technology will allow clinicians to directly monitor intrapartum fetal oxygenation. There are serious and significant limitations in the use of electronic fetal heart rate monitoring by cardiotocography (CTG) for monitoring fetal status during labor and detection of fetal compromise due to hypoxia. Owing to misinterpretation and inherent limitations of CTG, there is an intolerably high false positive rate (89%) for detecting fetal hypoxemia that has resulted in high rates of medically unnecessary cesarean deliveries. Cesarean delivery is not benign; it has potential adverse consequences for mothers and newborns and incurs substantial unnecessary healthcare cost. Furthermore, CTG false negatives, when fetal hypoxia is unrecognized owing to misinterpretation of CTG, result in devastating neonatal consequences, such as hypoxic ischemic encephalopathy that also incurs substantial healthcare cost. Monitoring fetal oxygenation in conjunction with CTG will provide a more precise modality of fetal surveillance during labor and delivery, safely reduce the use of medically unnecessary cesarean deliveries, and reduce the occurrence of newborns suffering consequences of metabolic acidosis In prior studies, supported by SBIR Phase I & II awards, Raydiant Oximetry: (i) developed computational models of fetal and maternal tissues in 2D and 3D to inform hardware design, algorithm development and feature set extraction; (ii) obtained first-in-human feasibility data in a clinical study of 6 pregnant women to validate the computational modeling efforts (clinicaltrials.gov: NCT04081623); and (iii) validated the approach with preclinical studies in the pregnant ewe model. The proposed Phase II SBIR builds directly upon these results. The goals of this research are to advance this technology towards commercialization by collecting human data training sets to refine the computational algorithm that allows separation of the fetal from maternal near infrared signals and then validate this algorithm to support an upcoming IDE filing with the FDA. This Phase II SBIR application is in response to the Notice of Special Interest (NOT-HD-21-053) from the NICHD to advance the development of non-invasive, physiological monitors that improve fetal assessment through the non- invasive measurement of fetal blood pH or oxygenation.

项目摘要 Raydiant Oximetry，Inc.（Raydiant）开发了一种新颖的光学传感技术（“LumerahTM”）并获得专利 通过无创、经腹的胎儿测量，直接评估分娩和分娩期间的胎儿状态， 氧合这项技术将使临床医生能够直接监测产时胎儿氧合。有 通过心脏分娩力描记术（CTG）进行的电子胎心率监测的严重和显著局限性， 在分娩过程中监测胎儿状态和检测由于缺氧引起的胎儿损伤。由于误解 由于CTG本身的局限性，胎儿低氧血症的假阳性率高达89 这导致了医学上不必要的剖腹产率很高。剖腹产不是良性的;它有 对母亲和新生儿的潜在不良后果，并导致大量不必要的医疗保健费用。 此外，当由于CTG的误解而未识别出胎儿缺氧时，CTG假阴性导致 毁灭性的新生儿后果，如缺氧缺血性脑病，也引起大量的 医疗费用。结合CTG监测胎儿氧合将提供一种更精确的胎儿氧合模式。 在分娩和分娩期间进行监测，安全地减少医学上不必要的剖宫产分娩，以及 减少新生儿患代谢性酸中毒的发生率 在之前的研究中，由SBIR第一阶段和第二阶段奖项支持，Raydiant血氧测定：（i）开发了计算模型， 2D和3D的胎儿和母体组织，为硬件设计、算法开发和功能集提供信息 提取;（ii）在6名孕妇的临床研究中获得首次人体可行性数据，以验证 计算建模工作（clinicaltrials.gov：NCT 04081623）;以及（iii）用临床前试验验证了该方法 妊娠母羊模型的研究。 拟议的第二阶段SBIR直接基于这些结果。这项研究的目标是推动这一点， 通过收集人类数据训练集来完善计算算法， 该算法允许胎儿与母体近红外信号分离，然后验证该算法以支持 即将向FDA提交的IDE文件 本第二阶段SBIR申请是对NICHD特别关注通知（NOT-HD-21-053）的回应， 推进非侵入性生理监测器的开发，通过非侵入性监测改善胎儿评估， 胎儿血液pH或氧合的侵入性测量。