A Smart, "Always -On" Health Monitoring System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2021-11-10

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

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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.

Conditions

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Premature Birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Wireless vitals monitor

Interventions

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Skin Sensor

Wireless vitals monitor

Intervention Type DEVICE

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

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes