ECG Device for LQTS Screening in Newborn

用于新生儿 LQTS 筛查的心电图设备

基本信息

批准号：
8396113
负责人：
RUEY-KANG R CHANG
金额：
$ 20万
依托单位：
PULSENTRY, INC.
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-08-01 至 2014-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8396113
关键词：
Accounting Age Cardiac Cessation of life Chest Child Clinical Clinical Data Clinical Research Clinical Trials Data Devices Early Diagnosis Electrocardiogram Electrodes Event FDA approved Feasibility Studies Heart Rate Home environment Hour Infant Instruction Internet Lead Length Limb structure Logistics Long QT Syndrome Mails Manikins Marketing Measurement Memory Modeling Morbidity - disease rate Neonatal Screening Newborn Infant Nurses Parents Performance Phase Physicians Positioning Attribute Postdoctoral Fellow Printing Production Research Infrastructure Screening procedure Shapes Staging Sudden Death Sudden infant death syndrome System Technology Testing Time Visit Wireless Technology Work Writing analog base commercialization cost cost effectiveness design digital experience follow-up improved meetings mortality phase 1 study phase 2 study prevent prototype safety testing sound transmission process validation studies young adult

项目摘要

DESCRIPTION (provided by applicant): Long QT syndrome (LQTS) occurs in 1 out of 2,500 infants, accounts for 10-15% of deaths due to sudden infant death syndrome (SIDS), and is a major cause of mortality and morbidity in infants, children, and young adults. Electrocardiograms (ECGs) can detect LQTS at a pre-symptomatic stage, and treatments are available to prevent cardiac events and death. ECGs have been shown to be effective in screening for LQTS in newborns 2-4 weeks of age. However, universal screening of newborns for LQTS cannot be implemented, due to many logistic and technological obstacles. To overcome the obstacles, we designed an ECG device specifically for newborn screening, with the following features: 1) appropriate size; 2) ease of use; 3) error-free lead placement; 4) improved sensitivity for screening due to long recording times; and 5) low cost. Moreover, we have developed the essential technologies for this device -- a pre-positioned electrode strip for newborns (which simplifies and reduces errors in lead placement) and an ultra-compact, low power platform for ECG recording and wireless transmission (called the Eco node). Building upon these technologies, we will complete the prototype newborn ECG device and validate its use in a clinical study of newborns. A compact ECG recorder module will be developed by integrating an analog frontend chip to the Eco node. The disposable electrode strip attaches to the recorder module via a snap-on connector to form the complete ECG device. In the Home Model of ECG screening, parents place the electrode strip on their baby and, after recoding is complete, remove the recorder module and mail it to a central lab. In the MD Office Model of screening, a nurse places the electrode strip on the baby at the 2-week well child visit, and the digital ECG data are transmitted wirelessly to the central lab via the Internet. We will conduct a clinical feasibility and validation study on 44 infants at 2-4 weeks of age. The QTc measurements from the newborn ECG device will be compared to those obtained by an FDA-approved digital ECG system. We will also test the feasibility of parent performance of ECGs, and determine the optimal length of ECG recordings for LQTS screening. PUBLIC HEALTH RELEVANCE: Long QT syndrome (LQTS) is a major cause of sudden death in infants, children, and young adults. Electrocardiograms (ECGs) are effective for early detection of LQTS, so that treatment can prevent sudden death. We will build on key technologies that we have developed to implement a compact, low- cost, accurate ECG device specifically designed for LQTS screening in newborns.

描述（由申请人提供）：长QT综合征（LQT）发生在2500名婴儿中的1例中，占由于猝死综合征（SIDS）而导致死亡的10-15％，是婴儿，儿童和年轻人死亡和发病率的主要原因。心电图（ECGS）可以在症状前阶段检测LQT，并且可以治疗以防止心脏事件和死亡。 ECG已被证明可有效筛查2-4周龄的新生儿LQT。但是，由于许多逻辑和技术障碍，无法实施对新生儿的普遍筛查。为了克服障碍，我们设计了一种专门用于新生儿筛查的ECG设备，具有以下功能：1）适当的尺寸； 2）易用性； 3）无错误的铅放置； 4）提高了由于长期记录时间而引起的筛查灵敏度； 5）低成本。此外，我们已经开发了该设备的必需技术 - 用于新生儿的预位电极条（简化和减少铅放置的错误）和超紧凑的，低功率的ECG记录和无线传输（称为ECO节点）。在这些技术的基础上，我们将完成新生儿ECG设备的原型，并验证其在新生儿临床研究中的使用。紧凑的ECG记录器模块将通过将模拟前端芯片集成到Eco节点来开发。一次性电极条通过快照连接器连接到录音机模块，以形成完整的ECG设备。在ECG筛查的家庭模型中，父母将电极条放在婴儿上，重新编码完成后，将录音机模块删除并将其邮寄到中央实验室。在MD筛查的MD办公室模型中，护士将电极条放在婴儿访问2周的婴儿访问中，并且数字ECG数据通过Internet无线传输到中央实验室。我们将对2-4周龄的44名婴儿进行临床可行性和验证研究。将将来自新生儿ECG设备的QTC测量与由FDA批准的数字ECG系统获得的测量值进行比较。我们还将测试ECG的父绩效的可行性，并确定LQTS筛选的ECG记录的最佳长度。公共卫生相关性：长QT综合征（LQTS）是婴儿，儿童和年轻人突然死亡的主要原因。心电图（ECG）可有效地对LQT进行早期检测，因此治疗可以预防猝死。我们将建立在开发的关键技术的基础上，以实施专门为LQTS筛查的新生儿设计的紧凑，低成本，准确的ECG设备。