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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06994494
Status
Recruiting
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Conditions

  • Hypotension
  • Unstable Blood Pressure

Eligibility Criteria

Sex
ALL
Age
24 Weeks - 44 Weeks
Healthy Volunteers
Not accepted

Study Details

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 Dates

Start date
Apr 9, 2025
Status verified
May 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Arterial Line Cohort
    We will recruit and measure neonates who are between ≥ 24 weeks and \< 44 weeks postmenstrual age, undergoing A-line BP monitoring for clinical reasons.
  • Arm: Cuff Cohort
    We will recruit and measure neonates in the same age range as in the A-line cohort who are at risk for unstable blood pressure but without A-line BP monitoring, as long as they can tolerate manual cuff-based BP measurements at intervals of at least 1-4 hours.

Primary Outcome Measure

FlexNIRS-based blood pressure estimation [ Time Frame: 04/09/2025 - 11/30/2026 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-
Massachusettes General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MAMassachusettes General Hospital· Boston, MA

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