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A Smart, "Always -On" Health Monitoring System

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Northwestern University

Status

Completed

Conditions

Premature Birth

Treatments

Device: Skin Sensor

Study type

Observational

Funder types

Other

Identifiers

NCT02865070
MA06072012

Details and patient eligibility

About

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

Full 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.

Enrollment

38 estimated patients

Sex

All

Ages

Under 6 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

38 participants in 9 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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