A Smart, "Always -On" Health Monitoring System

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