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Clinical Trial Summary

The primary objective of this study is to evaluate the feasibility of the use of an investigational wearable vital sign monitoring device in infants.


Clinical Trial Description

Vital sign monitoring of infants outside of a traditional healthcare setting has already been shown to significantly decrease mortality for children with single ventricle congenital heart disease (1V CHD), a fragile group of patients with congenital heart disease (CHD). Therefore, there is a critical need to develop an accurate, at-home vital sign monitoring system for infants to expand the benefits of remote monitoring to further patient populations. The investigators believe that allowing for continuous monitoring at a clinical standard with interpretations and alerts built into the technology will result in an even greater decline in mortality for infants with 1V CHD, improved clinical outcomes for all infants with CHD, and increased well-being for healthy infants. To achieve this goal, the investigators are developing a health monitoring system that collects numerical data and physiological waveforms describing heart rate (HR), respiratory rate (RR), pulse oximetry (SpO2), regional oxygen saturation, temperature, and infant motion. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05910320
Study type Interventional
Source Johns Hopkins University
Contact Kate Calligy, BSN
Phone 4432874117
Email kcummi15@jhmi.edu
Status Recruiting
Phase N/A
Start date May 23, 2023
Completion date May 23, 2025

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