Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs

NCT ID: NCT06382207

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-17
• Study Completion Date: 2026-02-28

Brief Summary

When a newborn is diagnosed with tachyarrhythmia, they are generally started on medical therapies, most commonly a beta-blocker, while being observed in an inpatient setting. In most academic institutions, current practice is to provide parental teaching on use of a stethoscope to auscultate their child when there is suspicion for distress, in addition to requiring cardiopulmonary resuscitation (CPR) classes. Fortunately, newer technologies have emerged that allow for capture of cardiac rhythm that may provide a buffer between the infant and the emergency room.

Detailed Description

Tachyarrhythmias which would prompt an emergent call to the pediatric cardiologist following the child, along with simultaneous transportation towards the nearest, preferably pediatric, emergency room. In reality, parental caregivers may be blinded by their personal anxiety in caring for their child with a tachyarrhythmia, and their interpretation or ability to count their child's heart beats may not be accurate. This in turn, can result in unnecessary calls and visits to the emergency room which increase their utilization in addition to piling onto the already astounding cost of healthcare in the United States. Fortunately, newer technologies have emerged that allow for capture of cardiac rhythm that may provide a buffer between the infant and the emergency room. Eko manufactures a digital stethoscope with 1-lead electrocardiogram (ECG), the DUO, which pairs with a mobile application that allows the clinician to further engage with the device during and after a clinical visit. The application enables the clinician to visualize the sounds and electrical signals coming from the device in real time.

Currently, the DUO is cleared for use on patients greater than or equal to 10 kg. This device may have additional clinical utility in pediatric patients <10 kg when used by either a physician or a parent/caregiver at home for remote patient monitoring. The CORE 500 may also have clinical utility in this patient population.

Conditions

Tachyarrhythmia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Digital Stethoscopes to measure neonatal tachyarrhythmias

Parental caregivers of infant research subjects are trained to use technology (digital stethoscopes) to decrease stress and unnecessary trips to the emergency room.

Group Type: OTHER

Eko Duo electronic stethoscope

Intervention Type: DEVICE

A digital stethoscope with 1-lead electrocardiogram (ECG), the DUO, which pairs with a mobile application that allows the clinician to further engage with the device during and after a clinical visit. The application enables the clinician to visualize the sounds and electrical signals coming from the device in real time.

CORE 500 electronic stethoscope

Intervention Type: DEVICE

The CORE 500 has 3 electrodes that produce a 3 lead ECG, which can be viewed through the Eko app. The CORE 500 also has a user interface screen which provides a number of functions including confirming when all three electrodes have good skin contact, showing a single lead ECG wave, providing heart rate, allowing the user to switch between audio modes, allowing the user to take recordings, and providing AI analysis results for recordings.

Interventions

Eko Duo electronic stethoscope

A digital stethoscope with 1-lead electrocardiogram (ECG), the DUO, which pairs with a mobile application that allows the clinician to further engage with the device during and after a clinical visit. The application enables the clinician to visualize the sounds and electrical signals coming from the device in real time.

Intervention Type: DEVICE

CORE 500 electronic stethoscope

The CORE 500 has 3 electrodes that produce a 3 lead ECG, which can be viewed through the Eko app. The CORE 500 also has a user interface screen which provides a number of functions including confirming when all three electrodes have good skin contact, showing a single lead ECG wave, providing heart rate, allowing the user to switch between audio modes, allowing the user to take recordings, and providing AI analysis results for recordings.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age <1 year
• No previous diagnosis of arrhythmia
• Parent/caregiver can provide informed consent
• Parent/caregiver can speak and understand simple English

Exclusion Criteria

• Age ≥ 1 year
• Patient has a pacemaker or implantable cardioverter defibrillator (ICD)
• Parent/caregiver is unwilling or unable to provide informed consent
• Parent/caregiver is unable to speak and understand English

• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eko Devices, Inc.

INDUSTRY

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Snyder

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christopher Snyder

Role: CONTACT

christopher.snyder@vcuhealth.org

8046284787

Margaret Lessard

Role: CONTACT

margaret.lessard@vcuhealth.org

804-628-3093

Facility Contacts

Christopher Snyder

Role: primary

christopher.snyder@vcuhealth.org

Margaret Lessard

Role: backup

margaret.lessard@vcuhealth.org

Other Identifiers

HM20029298

Identifier Type: -

Identifier Source: org_study_id