A Smart, "Always -On" Health Monitoring System

Northwestern University38 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Premature Birth

Interventions

Skin SensorDEVICE

Wireless vitals monitor

Eligibility

Sex: ALLMax age: 6 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Lurie Children's Hospital

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Correlation of vital parameters against current technology

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

Secondary Outcomes

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

Time frame: 24 hours, 1 week

Data from ClinicalTrials.gov

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