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