A Smart, "Always -On" Health Monitoring System

Completed

• Conditions: Premature Birth
• Interventions: Device: Skin Sensor

• Registration Number: NCT02865070
• Lead Sponsor: 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

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 Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-12
• Primary Completion: 2019-08-31
• Study Completion: 2021-11-10
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-12
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Correlation of vital parameters against current technology	15 min, 3 hours, 24 hours, 1 week

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lurie Children's Hospital; 🇺🇸 Chicago, Illinois, United States