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

Recruitingn/aAges 24 Weeks - 44 WeeksAllMassachusetts General Hospital
NCT06994494 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * Contraindication to FlexNIRS device placement on the scalp/head * Underlying congenital/genetic anomalies
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What it tests

  • Not listed
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Where

2 sites
Massachusettes General Hospital
Boston, United States
Brigham and Women's Hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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