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，在罗马怀孕之神之后，这种创新的制度将监测预期的母亲，以减轻出生期间对母子的风险。在此阶段I项目中，Orbital Research Inc.（俄亥俄州克利夫兰）及其MIT，Tufts-New England Medical Center和E-Trolz，Inc。的合作伙伴打算构建，然后测试一种新型的胎儿心电图（FECG）监测系统。胎儿心电图线束设备将是一个大型传感器阵列，可以方便而快速地应用于预期的母亲。基于服装的传感器阵列将允许传感器在单个步骤中放置在母亲的前，后部和侧面位置。服装将利用轨道研究干燥，ECG记录电极1，E-Trolz嵌入式平台以及MIT计算生理实验室的信号处理专业知识。提出的非侵入性胎儿监测器将可靠地获取胎儿心电图信号，并确定预测由炎症，低氧或缺血性损伤引起的胎儿损伤的特征性心电图模式。在此阶段I项目中，Orbital Research Inc（俄亥俄州克利夫兰）及其马萨诸塞州理工学院，Tufts医疗中心和E-Trolz，Inc。的合作伙伴将建立，测试和证明新型胎儿心电图（FECG）监测系统的可行性。最终的计划目标（II阶段完成后）是在怀孕和劳动期间生产一个可靠，廉价，无创的系统，用于胎儿监测。从该系统中获得的信息将在分娩过程中减轻对母亲和胎儿的风险，这将大大改善临床结果，尤其是从高风险交付中。 1 FDA清除。 ORI F6T干电器电极旨在用于使用标准ECG监视电极的所有ECG监控应用中。 F6T电极可在短期和长期（长达2天）的ECG监测中使用。公共卫生相关性：这种NONA的最终目标（非侵入性观察出生活动）计划是：1）开发一种可靠，廉价，无侵入性的系统，用于怀孕和劳动期间的胎儿监测以及2）确定可以预测劳动期间不良事件的FECG特征。第一阶段计划的结果将是完整系统的可行性 - 服装传感器，硬件和算法，以确定分娩时孩子的健康风险。成功完成第一阶段计划后，轨道团队将拥有：“制造了几种具有集成传感器的一次性服装”，从Tufts- New England Medical Center的一组女性中捕获了来自一组女性的数据，并且“展示的胎儿心率和FECG的组件可以通过与可用真实的Markers colleds collors colleors colleors colleors colleors colleds colleds calling cocks veecg识别。