Actively Recruiting
Noninvasive Continuous BP Monitoring in Newborns Based on Pulsatile Signal Morphological Features Using NIRS
Led by Massachusetts General Hospital · Updated on 2025-07-03
80
Participants Needed
2
Research Sites
85 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Noninvasive Continuous BP Monitoring in Newborns Based on Pulsatile Signal Morphological Features Using NIRS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonates aged 24 to less than 44 weeks postmenstrual age
- Hospitalized in newborn service units at Massachusetts General Hospital or Brigham and Women's Hospital
- For arterial line blood pressure monitoring: neonates expected to maintain arterial line monitoring for at least the next 12 hours
- For non-arterial line monitoring: neonates at risk for unstable blood pressure and no contraindications to manual cuff blood pressure measurements every 1 to 4 hours
You will not qualify if you...
- Contraindication to placing the FlexNIRS device on the scalp or head
- Presence of underlying congenital or genetic anomalies
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Massachusettes General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
E
Emily M Herzberg, MD
CONTACT
M
Mohamed A El-Dib, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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