ECG Device for LQTS Screening in Newborn

描述（由申请方提供）：长QT综合征（LQTS）发生在1/2，500名婴儿中，占婴儿猝死综合征（SIDS）所致死亡的10-15%，是婴儿、儿童和年轻成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LQTS，并且可以进行治疗以预防心脏事件和死亡。心电图已被证明是有效的筛查LQTS的新生儿2-4周的年龄。然而，由于许多后勤和技术障碍，无法对新生儿进行普遍的LQTS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ECG设备，具有以下特点：1）尺寸合适; 2）易于使用; 3）无错误的导线放置; 4）由于记录时间长，提高了筛查的灵敏度; 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（简化并减少电极导线放置的错误）和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）。在这些技术的基础上，我们将完成新生儿心电图设备的原型，并验证其在新生儿临床研究中的使用。将通过将模拟前端芯片集成到Eco节点来开发紧凑型ECG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，以形成完整的ECG设备。在家庭模式的心电图筛查中，父母将电极条放在婴儿身上，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办公室筛查模式中，护士在2周健康儿童访视时将电极条放在婴儿身上，数字ECG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验证研究。将新生儿ECG设备的QTc测量值与FDA批准的数字ECG系统获得的QTc测量值进行比较。我们还将测试父母进行ECG的可行性，并确定用于LQTS筛查的ECG记录的最佳长度。 公共卫生相关性：长QT综合征（LQTS）是婴儿、儿童和年轻人猝死的主要原因。心电图（ECG）对LQTS的早期检测是有效的，因此治疗可以防止猝死。我们将建立在我们已经开发的关键技术基础上，实现一种专为新生儿LQTS筛查设计的紧凑、低成本、准确的心电图设备。

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.