Noninvasive Continuous BP Monitoring in Newborns Based on Pulsatile Signal Morphological Features Using NIRS
Eligible age
0–0 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Massachusetts General Hospital
You may qualify if…
- ✓ Neonates ≥24 \& \<44 weeks postmenstrual age
- ✓ Hospitalization in MGH or BWH newborn service units
- ✓ For A-line BP monitoring: Neonates expected to maintain A-line monitoring for at least the next 12 hours
- ✓ For non-A-line monitoring: Neonates at risk for unstable blood pressure (e.g. clinical instability or need for inotropes) and no contraindications to manual cuff BP measurements every 1 to 4 hours
You may not qualify if…
- ✕ Contraindication to FlexNIRS device placement on the scalp/head
- ✕ Underlying congenital/genetic anomalies
Where it's recruiting
Boston
Source: ClinicalTrials.gov · NCT06994494 · last updated 2025-07-03