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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 10 months
View:

• 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

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Massachusettes General Hospital
RECRUITING
Boston
Contact Information
Primary
Emily M Herzberg, MD
eherzberg@mgh.harvard.edu
617 724 9040
Backup
Mohamed A El-Dib, MD
mel-dib@bwh.harvard.edu
617-732-6902
Time Frame
Start Date: 2025-04-09
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 80
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov