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NCT02865070 Clinical Trial

A Smart, "Always -On" Health Monitoring System

Premature Birth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02865070
Other study ID # MA06072012
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2016
Est. completion date November 10, 2021

Study information
Verified date June 2022
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date November 10, 2021
Est. primary completion date August 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 6 Months
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Skin Sensor
Wireless vitals monitor

Locations
Country Name City State
United States Lurie Children's Hospital Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation of vital parameters against current technology 15 min, 3 hours, 24 hours, 1 week
Secondary Adverse events from wireless monitoring sensor assessed through Neonatal Skin Condition Score (NSCS)-sub-study only 24 hours, 1 week
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