Advancing Fetal Assessment during Labor with Transabdominal Fetal Oximetry

项目摘要 Raydiant血氧仪公司(Raydiant)开发了一种新的光学传感技术(LumerahTM)并获得了专利。 通过非侵入性的经腹胎儿测量直接评估分娩和分娩期间的胎儿状况 氧合作用。这项技术将使临床医生能够直接监测分娩期间胎儿的氧合情况。确实有 使用电子胎心监护(CTG)进行胎心监护的严重和重大限制 在分娩过程中监测胎儿状态，并检测因缺氧而造成的胎儿损害。由于误解 和CTG的固有局限性，检测胎儿低氧血症的假阳性率高得令人无法忍受(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；它是 对母亲和新生儿可能产生不良后果，并产生大量不必要的医疗费用。 此外，由于对CTG的误解，当胎儿缺氧无法识别时，CTG假阴性会导致 毁灭性的新生儿后果，如缺氧缺血性脑病，也会导致 医疗保健成本。结合CTG监测胎儿氧合情况将提供更准确的胎儿 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腹产的使用，以及 减少新生儿代谢性酸中毒的发生 在之前的研究中，在SBIR第一阶段和第二阶段奖项的支持下，Raydiant血氧仪：(I)开发了 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)在对6名孕妇的临床研究中获得了第一个人类可行性数据，以验证 计算建模工作(Clinicaltrials.gov：NCT04081623)；以及(Iii)在临床前验证该方法 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的商业化技术 这允许从母亲的近红外信号中分离出胎儿，然后验证该算法以支持 即将向FDA提交的IDE文件。 此第二阶段SBIR申请是为了响应NICHD发出的特别关注通知(非HD-21-053)，以 推动非侵入性生理监护仪的发展，通过非侵入性、生理性监护仪改善胎儿评估 胎儿血液pH值或氧合的侵入性测量。

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.