A Smart, "Always -On" Health Monitoring System

June 12, 2022 updated by: Amy Paller, Northwestern University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Lurie Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Up to 110 premature babies in the Lurie Children's Hospital and Prentice Women's Hospital NICU within 1 week of birth that fall into one of the listed cohorts, fit inclusion and exclusion criteria

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Amy Paller, MD, Northwestern University, Lurie Children's Hospital Department of Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

November 10, 2021

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 12, 2016

Study Record Updates

Last Update Posted (Actual)

June 14, 2022

Last Update Submitted That Met QC Criteria

June 12, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA06072012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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