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Monitoring Blood Pressure in Newborns with FlexNIRS

This study is looking at a new way to measure blood pressure in newborns using a device called FlexNIRS. This device uses near-infrared light (NIRS) and is non-invasive, meaning it doesn't involve needles or surgery. The goal is to see if FlexNIRS can accurately measure blood pressure in babies who are at risk for unstable blood pressure, comparing it to the standard methods like arterial lines (a small tube placed in an artery) and blood pressure cuffs. If successful, this could offer a safer and continuous way to monitor blood pressure in critically ill newborns. The study is currently unclear on its recruitment status and plans to include 80 newborns between 24 and 44 weeks postmenstrual age who are hospitalized at MGH or BWH.

Study design
This is an observational study involving 80 newborns. It compares a new monitoring device to existing methods without giving any new treatments.
What's involved
Participants will wear a small, noninvasive NIRS sensor on their forehead. The study aims to collect data between April 2025 and November 2026.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT06994494

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

Recruiting
Not specifiedAges 24–44Observational
Massachusetts General Hospital
~80 participants
Updated 2025-07-03 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
FlexNIRS-based blood pressure estimation
Measured over 04/09/2025 - 11/30/2026

Conditions

Unstable Blood Pressure
Hypotension

Explore related trials

HypotensionStable blood pressure

Where it's being run

2 sites across 1 states
Massachusetts2

Who to contact

Emily M Herzberg, MD
[email protected]
617 724 9040
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Eligibility criteria

Inclusion

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

Contraindication to FlexNIRS device placement on the scalp/head
Underlying congenital/genetic anomalies

What this trial measures

  • FlexNIRS-based blood pressure estimation04/09/2025 - 11/30/2026

    Determine the correlation between FlexNIRS based blood pressure estimation and invasive A-line blood pressure as the gold standard or periodic BP cuff readings performed by clinical staff.