Status:
RECRUITING
Noninvasive Continuous BP Monitoring in Newborns Based on Pulsatile Signal Morphological Features Using NIRS
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Unstable Blood Pressure
Hypotension
Eligibility:
All Genders
24-44 years
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 ...
Detailed Description
Continuous blood pressure monitoring is important for critically ill newborns to prevent brain injury caused by dysregulated changes in cerebral perfusion. In addition, continuous blood pressure monit...
Eligibility Criteria
Inclusion
- 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
- Contraindication to FlexNIRS device placement on the scalp/head
- Underlying congenital/genetic anomalies
Key Trial Info
Start Date :
April 9 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06994494
Start Date
April 9 2025
End Date
November 30 2026
Last Update
July 3 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusettes General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115