ECG Device for LQTS Screening in Newborn

描述(申请人提供)：长QT间期综合征(LQTS)发生在2500名婴儿中的1名，占婴儿猝死综合征(SID)死亡的10%-15%，是婴儿、儿童和年轻人死亡和发病的主要原因。心电图(ECG)可以在症状前阶段检测出LQTS，并可进行治疗以防止心脏事件和死亡。ECG已被证明在2-4周大的新生儿中筛查LQTS是有效的。然而，由于许多后勤和技术障碍，无法实施新生儿LQTS的普遍筛查。为了克服这些障碍，我们设计了一种专门用于新生儿筛查的心电设备，具有以下特点：1)合适的尺寸；2)易于使用；3)无错误的导联放置；4)由于记录时间长而提高了筛查的灵敏度；5)低成本。此外，我们还开发了该设备的关键技术--用于新生儿的预置电极条(可简化和减少导线放置的错误)和用于心电记录和无线传输的超紧凑、低功耗平台(称为Eco节点)。在这些技术的基础上，我们将完成新生儿心电设备的原型，并验证其在新生儿临床研究中的应用。通过将模拟前端芯片集成到Eco节点上，开发了一个紧凑型心电记录仪模块。一次性电极条通过卡扣式连接器连接到记录器模块上，形成完整的心电装置。在家庭模式的心电筛查中，父母将电极条放在他们的婴儿身上，在记录完成后，取出记录器模块并将其邮寄到中心实验室。在MD Office模式的筛查中，护士在对婴儿进行为期2周的探视时将电极条放置在婴儿身上，数字心电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周龄的婴儿进行临床可行性和有效性研究。新生儿心电设备的QTC测量结果将与FDA批准的数字心电系统获得的结果进行比较。我们还将测试ECG亲代性能的可行性，并确定LQTS筛查的最佳心电记录长度。 公共卫生相关性：长QT综合征(LQTS)是导致婴儿、儿童和年轻人猝死的主要原因。心电图(ECG)是早期发现LQTS的有效方法，因此治疗可以防止猝死。我们将以我们开发的关键技术为基础，实施一种紧凑、低成本、准确的心电设备，专门为新生儿LQTS筛查设计。

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.