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

Launched by MASSACHUSETTS GENERAL HOSPITAL · May 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new device that uses a technique called near-infrared spectroscopy (NIRS) to monitor blood pressure in newborns who may have unstable blood pressure. The aim is to find out if this device can provide accurate blood pressure readings without needing to use more invasive methods, like an arterial line, or the traditional manual cuff method. By comparing the NIRS readings to these standard methods, researchers hope to ensure that the device works well and can be used safely on newborns.

To participate in this study, newborns must be between 24 and 44 weeks postmenstrual age and receiving care at specific hospital units. Eligible infants may be those who need closer blood pressure monitoring due to their medical condition. If enrolled, participants will wear a small, noninvasive sensor on their forehead that continuously measures blood pressure, providing a more comfortable option for monitoring. This trial is currently recruiting, and it's important to note that some infants may not be eligible if they have certain medical conditions or cannot use the NIRS device.

Gender

ALL

Eligibility criteria

• 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