Home › Low Blood Pressure › NCT06994494

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

Who can join

24 Weeks – 44 Weeks · All sexes

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

About the study

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.

Sponsor: Massachusetts General Hospital · Participants: 80 · Started: Apr 9, 2025

Contact the study team

• Emily M Herzberg, MD · Phone: 617 724 9040
• Mohamed A El-Dib, MD · Phone: 617-732-6902

Official record on ClinicalTrials.gov — NCT06994494

Locations in the U.S.

Conditions

• Low Blood Pressure

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.