RecruitingNot Applicable

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

United States80 participantsStarted 2025-04-09

Plain-language summary

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.

Who can participate

Age range

24 Weeks – 44 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

FlexNIRS-based blood pressure estimation

Timeframe: 04/09/2025 - 11/30/2026

Trial details

NCT IDNCT06994494

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-11-30

Contact for this trial

Emily M Herzberg, MD

617 724 9040 eherzberg@mgh.harvard.edu

View on ClinicalTrials.gov More Unstable Blood Pressure trials