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RECRUITING
NCT06994494

Noninvasive Continuous BP Monitoring in Newborns Based on Pulsatile Signal Morphological Features Using NIRS

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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

Locations (2)

Massachusettes General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States