A Smart, Always -On Health Monitoring System

Study Overview
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Brief Summary
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This is a pilot study is to test a wireless, skin-sensor device against current technology in the NICU to monitor vitals

Detailed Description
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This is a single center, prospective, observational study that will recruit subjects from Lurie Children's Hospital and Prentice Women's Hospital to test a new wireless vitals monitor against the current vitals monitors used in the NICU. Patients will be neonates in different age brackets.

Official Title
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A Smart, Always -On Health Monitoring System, Sub-Study: No Strings Attached: Wireless Sensor Technology in the Prentice NICU

Conditions
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Premature Birth

Intervention / Treatment
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* Device: Skin Sensor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neonates in different age cohorts from ages 25 weeks gestational age to fullterm infants or infants up to 6 months of age, selected with assistance of NICU staff Currently in NICU and requiring monitoring for heart rate, ECG, respiratory rate, temperature, and pulse oximetry Parents able to understand and provide informed consent for study Infants enrolled in the Pre-Vent study (sub-study only) Exclusion Criteria: Over 6 months of age Hemodynamic or other instability precluding testing of new monitoring with concurrent standards Infants at imminent risk of death and neonates with a skin abnormality that precludes assessment

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 2 infants (ages 1-6mo) non-NICU setting<br> | Device: Skin Sensor<br>* Wireless vitals monitor<br>|
| 10 babies (full term, ages 37-42 weeks)<br> | Device: Skin Sensor<br>* Wireless vitals monitor<br>|
| 5 babies (premature, ages 34-37 weeks)<br> | Device: Skin Sensor<br>* Wireless vitals monitor<br>|
| 5 babies (premature, ages 31-34 weeks)<br> | Device: Skin Sensor<br>* Wireless vitals monitor<br>|
| 5 babies (premature, ages 28-31 weeks)<br> | Device: Skin Sensor<br>* Wireless vitals monitor<br>|
| 5 babies (premature, ages 25-28 weeks)<br> | Device: Skin Sensor<br>* Wireless vitals monitor<br>|
| 5 babies (premature, ages 23-25 weeks)<br> | Device: Skin Sensor<br>* Wireless vitals monitor<br>|
| 30 babies (any gestational age under 6 months)<br> | Device: Skin Sensor<br>* Wireless vitals monitor<br>|
| 25 neonates (ages 24-29 weeks for sub-study)<br> | Device: Skin Sensor<br>* Wireless vitals monitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of vital parameters against current technology |  | 15 min, 3 hours, 24 hours, 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events from wireless monitoring sensor assessed through Neonatal Skin Condition Score (NSCS)-sub-study only |  | 24 hours, 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premature, wireless vitals, vitals monitor