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

Northwestern University1 site in 1 country38 target enrollmentMarch 2016

ConditionsPremature Birth

Overview

Phase: N/A
Intervention: Not specified
Conditions: Premature Birth
Sponsor: Northwestern University
Enrollment: 38
Locations: 1
Primary Endpoint: Correlation of vital parameters against current technology
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

November 10, 2021

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Northwestern University

Responsible Party

Principal Investigator

Amy Paller

Professor in Dermatology and Pediatrics

Northwestern University

Eligibility Criteria

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