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CompletedNCT02865070Updated Jun 14, 2022

A Smart, "Always -On" Health Monitoring System

An observational study in Premature Birth, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged Up to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-14.

Sponsored by Northwestern University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
38
Ages
Up to 6 Months
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Premature Birth

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Keywords

  • premature
  • wireless vitals
  • vitals monitor
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's planned enrollment of 38 is below the median of 112 across 777 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 6 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
38 participants (estimated)
Patient registry
No

Groups and cohorts

  • 2 infants (ages 1-6mo) non-NICU setting

    Device: Skin Sensor

  • 10 babies (full term, ages 37-42 weeks)

    Device: Skin Sensor

  • 5 babies (premature, ages 34-37 weeks)

    Device: Skin Sensor

  • 5 babies (premature, ages 31-34 weeks)

    Device: Skin Sensor

  • 5 babies (premature, ages 28-31 weeks)

    Device: Skin Sensor

  • 5 babies (premature, ages 25-28 weeks)

    Device: Skin Sensor

  • 5 babies (premature, ages 23-25 weeks)

    Device: Skin Sensor

  • 30 babies (any gestational age under 6 months)

    Device: Skin Sensor

  • 25 neonates (ages 24-29 weeks for sub-study)

    Device: Skin Sensor

Interventions

  • DeviceSkin Sensor

    Wireless vitals monitor

06

What researchers measure

Primary outcomes

  1. Correlation of vital parameters against current technology

    Time frame: 15 min, 3 hours, 24 hours, 1 week

Secondary outcomes

  1. Adverse events from wireless monitoring sensor assessed through Neonatal Skin Condition Score (NSCS)-sub-study only

    Time frame: 24 hours, 1 week

07

Study locations

1 site
  • Lurie Children's Hospital
    Chicago, Illinois 60611, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02865070
Lead sponsor
Northwestern University
Responsible party
Amy Paller (Professor in Dermatology and Pediatrics, Northwestern University) — Principal investigator
First posted
Aug 12, 2016
Start date
Mar 2016
Primary completion
Aug 31, 2019
Completion
Nov 10, 2021
Last update
Jun 14, 2022

Study contacts

Amy Paller, MD
principal investigator · Northwestern University, Lurie Children's Hospital Department of Dermatology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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