Status:

TERMINATED

Advancing the Science of Pediatric Interstage Home Monitoring

Lead Sponsor:

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborating Sponsors:

Sibel Health Inc.

Conditions:

Heart Defects, Congenital

Eligibility:

All Genders

Up to 2 years

Brief Summary

The overall goal of this study is to understand the feasibility of using a wireless sensor device (instead of a wired device) to collect information used to monitor children with heart conditions at h...

Detailed Description

The goal of this study is to examine how well continuous sensor-based monitoring performs at detecting physiologic data in infants with single ventricle physiology at home compared to existing approac...

Eligibility Criteria

Inclusion

  • Receiving active remote patient monitoring (RPM) in Lurie's Tele-Interstage Home Monitoring Program.
  • Age 0-2 years of age at enrollment.
  • In the opinion of the investigator, parent or legally authorized guardian, and participant, the participant and (when relevant) family can follow study procedures.

Exclusion

  • Is going to discontinue RPM before their enrollment would end (i.e., within 14 days).
  • Skin breakdown or severe rash at the site of sensor placement.
  • Patient without a parental guardian to consent.
  • The patient is in active hospice or similar end-of-life care.
  • The patient will be living in a long-term institution or transitional facility.

Key Trial Info

Start Date :

July 24 2024

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 30 2025

Estimated Enrollment :

2 Patients enrolled

Trial Details

Trial ID

NCT06547268

Start Date

July 24 2024

End Date

October 30 2025

Last Update

October 31 2025

Active Locations (1)

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1

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60611