Digital Stethoscope for Rapid Heartbeat in Infants

Overseen By Christopher Snyder

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Must be taking: Beta-blockers

Disqualifiers: Age ≥ 1 year, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Christopher Snyder

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for infants under 1 year old with rapid heartbeat conditions, where parents can give consent and understand simple English. Infants with a pacemaker or ICD, or whose caregivers cannot consent or understand English are excluded.

Inclusion Criteria

I am under 1 year old.

Parent/caregiver can provide informed consent

Parent/caregiver can speak and understand simple English

Exclusion Criteria

Patient has a pacemaker or implantable cardioverter defibrillator (ICD)

Parent/caregiver is unwilling or unable to provide informed consent

I am at least 1 year old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Training

Parental caregivers are trained to use digital stethoscopes to measure neonatal tachyarrhythmias

1 week

1 visit (in-person)

Baseline Assessment

Good-quality ECG recordings are taken by parents/caregivers with and without a physician present

1 week

2 visits (in-person)

Home Monitoring

Parents/caregivers take ECG recordings at home using the CORE 500 device

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after home monitoring

2 weeks

Treatment Details

Interventions

• CORE 500 electronic stethoscope
• Eko Duo electronic stethoscope

Trial Overview The study tests two electronic stethoscopes (Eko Duo and CORE 500) to see if they're effective in capturing the heart's electrical activity in babies with fast heart rates, potentially reducing ER visits.

Participant Groups

Group I: Digital Stethoscopes to measure neonatal tachyarrhythmias Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Eko Devices, Inc.

Industry Sponsor

Trials

14

Recruited

8,000+