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NONA Garment Project: Noninvasive Observation of Natal Activity

NONA 服装项目：无创观察胎儿活动

基本信息

批准号：
7613285
负责人：
Aaron T Rood
金额：
$ 18.15万
依托单位：
ORBITAL RESEARCH, INC.
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-05-01 至 2010-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7613285
关键词：
Abdomen Abscess Address Adhesives Adverse event Algorithms Anterior Birth Birthing Centers Cardiac Cervix Uteri Characteristics Chest Child Childbirth Clinical Data Databases Devices Discipline of obstetrics Doppler Ultrasound Electrocardiogram Electrodes Equipment Fetal Heart Rate Fetal Monitoring Fetal Movement Fetus Goals Gold Health Hypoxia Inflammatory Injury Institutes Laboratories Lateral Lead Location Massachusetts Medical center Membrane Mind Monitor Mothers Names New England Ohio Outcome Patients Pattern Phase Physiological Physiology Positioning Attribute Postpartum Period Pregnancy Pregnant Women Preparation Relative (related person)Reporting Research Research Design Risk Rupture Scalp structure Series Signal Transduction Small Business Innovation Research Grant System Technology Testing Woman Work Writing base computerized data processing data acquisition design fetal high risk improved innovation kinematics maternal separation non-invasive system novel pregnant programs prototype public health relevance sensor software development

项目摘要

DESCRIPTION (provided by applicant): Named NONA, after the Roman God of pregnancy this innovative system will monitor the expectant mother to mitigate the risk to mother and child during birth. During this Phase I project, Orbital Research Inc. (Cleveland, Ohio), with their partners at MIT, Tufts-New England Medical Center and E-Trolz, Inc., intends to build, then test a novel fetal electrocardiograph (FECG) monitoring system. The fetal ECG harness device will be a large sensor array that can be applied in a convenient and rapid manner to an expectant mother. The garment-based sensor array will allow sensors to be placed in anterior, posterior and lateral positions on the mother in a single step. The garment will leverage the Orbital Research dry, ECG recording electrodes1, the E-Trolz embedded platform, and signal processing expertise from the laboratory for computational physiology at MIT. The proposed non-invasive fetal monitor will reliably acquire fetal ECG signals, and identify characteristic ECG patterns that predict impending fetal injury caused by inflammatory, hypoxic, or ischemic insults. During this Phase I project, Orbital Research Inc (Cleveland, Ohio), with their partners at the Massachusetts Institute of Technology, Tufts Medical Center, and E-Trolz, Inc., will build, test and demonstrate the feasibility of a novel fetal electrocardiograph (FECG) monitoring system. The ultimate program goal (after completion of Phase II) is to produce a reliable, inexpensive, non-invasive system for fetal monitoring during pregnancy and labor. The information gained from this system will mitigate risk to the mother and fetus during delivery which will dramatically improve clinical outcomes especially from high risk deliveries. 1 FDA cleared. The ORI F6T Dry ECG Electrode is intended for use in all ECG monitoring applications where standard ECG monitoring electrodes are used. The F6T Electrode can be used in short term and long term (up to 2 days) ECG monitoring. PUBLIC HEALTH RELEVANCE: The ultimate goals of this NONA (Non-Invasive Observation of Natal Activity) program are: 1) To develop a reliable, inexpensive, non-invasive system for fetal monitoring during pregnancy and labor, and 2) to identify FECG characteristics that predict adverse events during labor and the immediate postpartum period. The Phase I program outcome will be the demonstration of the feasibility of the complete system - garment- sensors, hardware, and algorithms to identify health risk to the child during childbirth. Upon successful completion of the Phase I program, the Orbital Team will have: " fabricated several disposable garments with integrated sensors, " captured data from a set of women in the birthing center at TUFTS- New England Medical Center, and " demonstrated fetal heart rate and components of FECG can be identified accurately using Kalman Filtering relative to the available truth markers collected via the scalp sensor.

描述（由申请人提供）：命名为NONA，在罗马神的怀孕后，这一创新系统将监测准妈妈，以减轻风险，母亲和孩子在出生期间。在第一阶段项目中，轨道研究公司。（克利夫兰，俄亥俄州），与他们的合作伙伴在麻省理工学院，塔夫茨-新英格兰医疗中心和E-Trolz公司，本课题旨在研制并测试一种新型的胎儿心电监护系统。胎儿ECG安全带装置将是可以以方便和快速的方式应用于准妈妈的大型传感器阵列。基于衣服的传感器阵列将允许传感器在单个步骤中被放置在母亲的前部、后部和侧部位置。该服装将利用Orbital Research的干式ECG记录电极1、E-Trolz嵌入式平台以及麻省理工学院计算生理学实验室的信号处理专业知识。所提出的无创胎儿监护仪将可靠地采集胎儿ECG信号，并识别特征ECG模式，预测即将发生的胎儿损伤引起的炎症，缺氧或缺血性损伤。在这个第一阶段项目中，轨道研究公司（克利夫兰，俄亥俄州），与他们的合作伙伴在马萨诸塞州理工学院，塔夫茨医疗中心，和E-Trolz公司，将建立，测试和证明一种新的胎儿心电图（FECG）监测系统的可行性。最终的计划目标（第二阶段完成后）是生产一个可靠的，廉价的，非侵入性的系统，用于妊娠和分娩期间的胎儿监测。从该系统获得的信息将减轻分娩期间母亲和胎儿的风险，这将大大改善临床结局，特别是高风险分娩。1个FDA批准。ORI F6 T干式ECG电极预期用于使用标准ECG监测电极的所有ECG监测应用。F6 T电极可用于短期和长期（最多2天）ECG监测。公共卫生关系：该NONA（纳塔尔活动的无创观察）计划的最终目标是：1）开发一种可靠、廉价、无创的系统，用于妊娠和分娩期间的胎儿监测; 2）识别可预测分娩期间和产后即刻不良事件的FECG特征。第一阶段计划的成果将是展示完整系统的可行性-服装-传感器，硬件和算法，以识别分娩期间儿童的健康风险。在第一阶段计划成功完成后，轨道团队将：“制造几件带有集成传感器的一次性服装“，从Tufts-新英格兰医疗中心的分娩中心的一组妇女那里捕获数据，并“证明相对于通过头皮传感器收集的可用真值标记，可以使用卡尔曼滤波准确识别胎儿心率和FECG的组成部分。