Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants
- Conditions
- Congenital Heart Disease in Children
- Interventions
- Device: Wearable Vital Signs Monitoring Device
- Registration Number
- NCT05910320
- Lead Sponsor
- Johns Hopkins University
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- Patient admitted to either the newborn nursery, pediatric cardiac intensive care unit (PCICU), or pediatric care unit (PCU)
- Parent provided written informed consent
- Foster or ward of the state
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Wearable Vital Signs Monitoring Device Wearable Vital Signs Monitoring Device -
- Primary Outcome Measures
Name Time Method Signal morphology of wearable monitoring device From device placement to removal, up to 1 hour Feasibility of a wearable monitoring device as determined by signal morphology of wearable monitoring device
Signal-to-noise ratio of wearable monitoring device From device placement to removal, up to 1 hour Feasibility of a wearable monitoring device as determined by signal-to-noise ratio
Signal-to-noise ratio of reusable electrodes From electrode placement to removal, up to 15 minutes Feasibility of reusable electrodes as determined by the signal-to-noise ratio
Percent error of wearable monitoring device compared to clinical bedside monitors From device placement to removal, up to 1 hour Feasibility of a wearable monitoring device as determined by percent error compared to clinical bedside monitors
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Johns Hopkins Children's Center
🇺🇸Baltimore, Maryland, United States