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Search / Trial NCT06994494

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

Launched by MASSACHUSETTS GENERAL HOSPITAL · May 20, 2025

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Non Invasive Blood Pressure Monitoring Arterial Line Nirs Wearable Device Cerebral Oximetry

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

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported