Recruiting

NIRS

Sponsor:

Massachusetts General Hospital

Code:

NCT06994494

Conditions

Unstable Blood Pressure

Hypotension

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Unstable Blood Pressure

Hypotension

Study ID

NCT06994494

Start date

Apr 9, 2025

Status verified date

May, 2025

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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 and Locations

Central contacts

Emily M Herzberg, MD

617 724 9040eherzberg@mgh.harvard.edu

Mohamed A El-Dib, MD

617-732-6902mel-dib@bwh.harvard.edu

Locations

Massachusettes General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 3, 2025

Last verified

May, 2025

Keywords

  • Non-invasive blood pressure monitoring
  • Arterial Line
  • NIRS
  • wearable device
  • Cerebral oximetry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-07-03.