Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants

Conditions
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Congenital Heart Disease in Children

Intervention / Treatment
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* Device: Wearable Vital Signs Monitoring Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient admitted to either the newborn nursery, pediatric cardiac intensive care unit (PCICU), or pediatric care unit (PCU) Parent provided written informed consent Exclusion Criteria: Foster or ward of the state

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wearable Vital Signs Monitoring Device<br> | Device: Wearable Vital Signs Monitoring Device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |