Premature Birth
Conditions
Keywords
premature, wireless vitals, vitals monitor
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.
Interventions
DEVICESkin Sensor
Wireless vitals monitor
Sponsors
Northwestern University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation of vital parameters against current technology | 15 min, 3 hours, 24 hours, 1 week |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events from wireless monitoring sensor assessed through Neonatal Skin Condition Score (NSCS)-sub-study only | 24 hours, 1 week |
Countries
United States
Outcome results
None listed