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）：以罗马怀孕之神 NONA 命名的这一创新系统将监测准妈妈，以减轻分娩过程中母亲和孩子的风险。在第一阶段项目中，Orbital Research Inc.（俄亥俄州克利夫兰）与麻省理工学院、塔夫茨-新英格兰医学中心和 E-Trolz, Inc. 的合作伙伴打算构建并测试一种新型胎儿心电图 (FECG) 监测系统。胎儿心电图吊带装置将是一个大型传感器阵列，可以方便快捷地应用于准妈妈身上。基于服装的传感器阵列将允许传感器一步放置在母亲的前面、后面和侧面位置。该服装将利用 Orbital Research 干式心电图记录电极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。所提出的非侵入性胎儿监护仪将可靠地采集胎儿心电图信号，并识别特征性心电图模式，预测由炎症、缺氧或缺血性损伤引起的即将发生的胎儿损伤。在第一阶段项目中，Orbital Research Inc（俄亥俄州克利夫兰）与麻省理工学院、塔夫茨医学中心和 E-Trolz, Inc. 的合作伙伴将构建、测试并展示新型胎儿心电图仪的可行性（FECG）监测系统。最终项目目标（第二阶段完成后）是生产一种可靠、廉价、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过程中母亲和胎儿的风险，这将显着改善临床结果，尤其是高风险分娩的临床结果。 1 FDA 批准。 ORI F6T 干式心电图电极适用于所有使用标准心电图监测电极的心电图监测应用。 F6T 电极可用于短期和长期（最多 2 天）心电图监测。公共健康相关性：NONA（出生活动无创观察）计划的最终目标是：1) 开发一种可靠、廉价、无创的怀孕和分娩期间胎儿监测系统，2) 识别 FECG 特征预测分娩期间和产后不久的不良事件。第一阶段计划的成果将展示整个系统的可行性——服装传感器、硬件和算法，以识别孩子在分娩过程中的健康风险。成功完成第一阶段计划后，轨道团队将：“制造几件带有集成传感器的一次性服装，”从 TUFTS 新英格兰医学中心分娩中心的一组妇女那里捕获数据，并“展示胎儿心率相对于通过头皮传感器收集的可用真实标记，可以使用卡尔曼滤波准确识别 FECG 的组成部分。