Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Wearable Vital Signs Monitoring Device
|
Device: Wearable Vital Signs Monitoring 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.
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Outcome Measures
Primary Outcome Measures
- Feasibility of a wearable monitoring device as determined by signal morphology [From device placement to removal, up to 1 hour]
- Feasibility of a wearable monitoring device as determined by signal-to-noise ratio [From device placement to removal, up to 1 hour]
- Feasibility of reusable electrodes as determined by the signal-to-noise ratio [From electrode placement to removal, up to 15 minutes]
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient admitted to either the newborn nursery, pediatric cardiac intensive care unit (PCICU), or pediatric care unit (PCU)
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Parent provided written informed consent
Exclusion Criteria:
- Foster or ward of the state
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins Children's Center | Baltimore | Maryland | United States | 21287 |
Sponsors and Collaborators
- Johns Hopkins University
Investigators
- Principal Investigator: Danielle Gottlieb Sen, MD, Johns Hopkins School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00361015