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A Smart, "Always -On" Health Monitoring System

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ClinicalTrials.gov Identifier: NCT02865070
Recruitment Status : Recruiting
First Posted : August 12, 2016
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Amy Paller, Northwestern University

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

Condition or disease Intervention/treatment
Premature Birth Device: Skin Sensor

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.

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Smart, "Always -On" Health Monitoring System, Sub-Study: No Strings Attached: Wireless Sensor Technology in the Prentice NICU
Study Start Date : March 2016
Actual Primary Completion Date : August 31, 2019
Estimated Study Completion Date : March 2020

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




Primary Outcome Measures :
  1. Correlation of vital parameters against current technology [ Time Frame: 15 min, 3 hours, 24 hours, 1 week ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865070


Contacts
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Contact: Dermatology CTU 312-503-5944 NUdermatologyCTU@northwestern.edu

Locations
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United States, Illinois
Lurie Children's Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Dermatology CTU    312-503-5944    NUdermatologyCTU@northwestern.edu   
Principal Investigator: Amy Paller, MD         
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Amy Paller, MD Northwestern University, Lurie Children's Hospital Department of Dermatology

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Responsible Party: Amy Paller, Professor in Dermatology and Pediatrics, Northwestern University
ClinicalTrials.gov Identifier: NCT02865070    
Other Study ID Numbers: MA06072012
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Keywords provided by Amy Paller, Northwestern University:
premature
wireless vitals
vitals monitor
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications