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）：每 2,500 名婴儿中就有 1 名患有长 QT 综合征 (LQTS)，占婴儿猝死综合征 (SIDS) 死亡人数的 10-15%，是婴儿死亡和发病的主要原因、儿童和年轻人。心电图 (ECG) 可以在症状出现前阶段检测 LQTS，并且可以采取治疗措施来预防心脏事件和死亡。心电图已被证明可有效筛查 2-4 周龄新生儿的 LQTS。然而，由于许多后勤和技术障碍，新生儿 LQTS 的普遍筛查无法实施。为了克服这些障碍，我们设计了一款专门用于新生儿筛查的心电图设备，具有以下特点：1）尺寸合适； 2）易用性； 3）无错误引线放置； 4）由于记录时间长，提高了筛选的灵敏度； 5）成本低。此外，我们还开发了该设备的基本技术——用于新生儿的预定位电极条（可简化并减少导联放置错误）以及用于心电图记录和无线传输的超紧凑、低功耗平台（称为 Eco）。节点）。基于这些技术，我们将完成新生儿心电图设备原型并验证其在新生儿临床研究中的使用。通过将模拟前端芯片集成到 Eco 节点，将开发紧凑型心电图记录器模块。一次性电极条通过卡扣式连接器连接到记录仪模块，形成完整的心电图设备。在心电图筛查的家庭模式中，父母将电极条放在婴儿身上，完成重新编码后，取下记录器模块并将其邮寄到中心实验室。在医学博士办公室筛查模式中，护士在两周的儿童健康检查中将电极条放在婴儿身上，数字心电图数据通过互联网无线传输到中心实验室。我们将对 44 名 2-4 周龄婴儿进行临床可行性和验证研究。新生儿心电图设备的 QTc 测量值将与 FDA 批准的数字心电图系统获得的测量值进行比较。我们还将测试家长表现心电图的可行性，并确定用于 LQTS 筛查的心电图记录的最佳长度。公共卫生相关性：长 QT 综合征 (LQTS) 是婴儿、儿童和年轻人猝死的主要原因。心电图 (ECG) 对于早期发现 LQTS 非常有效，这样治疗就可以预防猝死。我们将利用我们开发的关键技术来实施专门为新生儿 LQTS 筛查而设计的紧凑、低成本、准确的心电图设备。