A Smart, "Always -On" Health Monitoring System
Completed
- Conditions
- Premature Birth
- 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.
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)
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What biomarkers does the wireless skin sensor monitor in preterm neonates compared to standard NICU devices?
How does the wireless sensor's accuracy in tracking heart rate and oxygen saturation compare to traditional NICU monitors in premature infants?
What adverse events are associated with wireless skin-sensor technology in neonatal intensive care settings?
Are there specific molecular pathways or physiological parameters targeted by the wireless sensor for early detection of complications in preterm birth?
What alternative wireless monitoring systems are being evaluated for neonatal care alongside NCT02865070's intervention?
Trial Locations
- Locations (1)
Lurie Children's Hospital
🇺🇸Chicago, Illinois, United States
Lurie Children's Hospital🇺🇸Chicago, Illinois, United States