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Development of a portable beat-to-beat fetal ECG system

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HD109072-01
Agency Tracking Number: R41HD109072
Amount: $256,322.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NICHD
Solicitation Number: PA21-262
Solicitation Year: 2021
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-01-18
Award End Date (Contract End Date): 2023-12-31
Small Business Information
Dayton, MD 21036-1142
United States
DUNS: 079727453
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (202) 476-6552
Business Contact
Phone: (919) 413-7321
Research Institution
WASHINGTON, DC 20010-2916
United States

 Domestic Nonprofit Research Organization

Project Summary
There are 24,000 stillbirths per year in the United States, and 2.6 million stillbirths per year
worldwide, with no significant decrease in the last decade. Abnormal fetal heart rhythms, such
as long QT syndrome, are thought to play an important role in these deaths, and may cause 3-
10% of unexplained stillbirths. This is in addition to known fetal arrhythmias, which affect 1-3%
of pregnancies per year. A magnetocardiogram is the gold standard to detect these disorders,
but is not portable or practical for widespread use. Other available tools such as ultrasound and
cardiotocography cannot measure the intervals needed to diagnose and guide management of
life threatening arrhythmias. The ideal tool for diagnosing and guiding therapy for arrhythmias is
an electrocardiogram (ECG). Unfortunately, clinicians do not widely use the existing fetal
electrocardiogram (fECG) devices for a variety of reasons: they do not work throughout all of
gestation, can miss brief arrhythmias, have a delay between the actual rhythm and displayed
rhythm, do not work in multiple gestations, and lack resolution of important intervals.
Our team has refined a prototype fECG during an ongoing R21 funded study. This proposal will
build on our preliminary work to create a compact version of the fECG which can be utilized
more widely in ambulatory settings. In this proposal we aim to:
1. Develop a compact amplifier system
2. Develop a new user interface
3. Pilot test the new system in a cohort of ten pregnant women carrying fetuses 22-40weeks gestation to determine whether it is comparable to or superior to the currentsystem in fECG quality and CTI measurements.
If successful, fetal cardiologists could use this tool to diagnose and treat known and latent fetal
arrhythmias. Globally, it could serve as a low cost tool to screen for arrhythmias that lead to
stillbirth and to monitor fetuses for compromise during surgery, maternal medication use, and
fetal interventions. Clinically implementing this critical diagnostic tool will be a landmark in the
field of fetal cardiology.

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

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