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Closed at site. Investigator no longer at site.
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The primary objective of this study is to evaluate the feasibility of the use of an investigational wearable vital sign monitoring device in infants.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wearable Vital Signs Monitoring Device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable Vital Signs Monitoring Device | Device | The prototype will be used to non-invasively measure vital signs. This prototype (preliminary version) is composed of a sensor module, a rechargeable battery, and electrodes. The device is housed in a waterproof, silicone casing. |
| Measure | Description | Time Frame |
|---|---|---|
| Signal morphology of wearable monitoring device | Feasibility of a wearable monitoring device as determined by signal morphology of wearable monitoring device | From device placement to removal, up to 1 hour |
| Signal-to-noise ratio of wearable monitoring device | Feasibility of a wearable monitoring device as determined by signal-to-noise ratio | From device placement to removal, up to 1 hour |
| Signal-to-noise ratio of reusable electrodes | Feasibility of reusable electrodes as determined by the signal-to-noise ratio | From electrode placement to removal, up to 15 minutes |
| Percent error of wearable monitoring device compared to clinical bedside monitors | Feasibility of a wearable monitoring device as determined by percent error compared to clinical bedside monitors | From device placement to removal, up to 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danielle Gottlieb Sen, MD | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Children's Center | Baltimore | Maryland | 21287 | United States |
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