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Noninvasive Continuous BP Monitoring in Newborns Based on Pulsatile Signal Morphological Features Using NIRS
Sponsor: Massachusetts General Hospital
Summary
The goal of this study is to evaluate if a novel near-infrared spectroscopy (NIRS) device can accurately estimate blood pressure in newborns at risk for unstable blood pressure. The main questions it aims to answer are: * Can NIRS accurately estimate blood pressure when compared to the gold standard, arterial line blood pressure * Can NIRS accurately estimate blood pressure when compared to infants with cuff blood pressure monitoring Researchers will compare NIRS-based estimates to arterial line blood pressure readings and manual cuff measurements to optimize and validate the FlexNIRS device for neonates to accurately estimate blood pressure continuously and noninvasively. Participants will wear a small, noninvasive NIRS sensor on the forehead.
Key Details
Gender
All
Age Range
24 Weeks - 44 Weeks
Study Type
OBSERVATIONAL
Enrollment
80
Start Date
2025-04-09
Completion Date
2026-11-30
Last Updated
2025-07-03
Healthy Volunteers
Not specified
Conditions
Locations (2)
Massachusettes General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States