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ECG Device for LQTS Screening in Newborn

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HL112435-01A1
Agency Tracking Number: R41HL112435
Amount: $199,990.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA10-118
Timeline
Solicitation Year: 2012
Award Year: 2012
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
46 Peninsula Ctr Ste E347
Rolling Hills Estates, CA 90274-3558
United States
DUNS: 965086205
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 RUEY-KANG CHANG
 (310) 222-4000
 rkchang@ucla.edu
Business Contact
 STUART CRILEY
Phone: (310) 375-4466
Email: stuart@pulsentry.com
Research Institution
 UNIVERSITY OF CALIFORNIA LOS ANGELES
 
UNIVERSITY OF CALIFORNIA LOS ANGELES Office of Research Administration 11000 Kinross Avenue, Suite 211
LOS ANGELES, CA 90095-
United States

 () -
 Nonprofit College or University
Abstract

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 reduceserrors 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-weekwell 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 willbe 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.

* Information listed above is at the time of submission. *

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