ECG Device for LQTS Screening in Newborn

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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.