Noninvasive blood pressure monitoring in newborns using a new device
Noninvasive Continuous BP Monitoring in Newborns Based on Pulsatile Signal Morphological Features Using NIRS
Massachusetts General Hospital · NCT06994494
This study is testing a new device that uses light to measure blood pressure in newborns to see if it works better than traditional methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 24 Weeks to 44 Weeks |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06994494 on ClinicalTrials.gov |
What this trial studies
This study evaluates the accuracy of a novel near-infrared spectroscopy (NIRS) device in estimating blood pressure in newborns at risk for unstable blood pressure. Researchers will compare the NIRS-based estimates to traditional arterial line blood pressure readings and manual cuff measurements. The goal is to optimize and validate the FlexNIRS device for continuous and noninvasive blood pressure monitoring in neonates, which is crucial for preventing brain injury and managing various neonatal conditions. Participants will wear a small, noninvasive NIRS sensor on their forehead during the monitoring process.
Who should consider this trial
Good fit: Ideal candidates include neonates aged 24 to 44 weeks postmenstrual age who are hospitalized and at risk for unstable blood pressure.
Not a fit: Patients with contraindications to the FlexNIRS device placement or those with underlying congenital or genetic anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a safer, noninvasive method for continuous blood pressure monitoring in critically ill newborns.
How similar studies have performed: While the approach of using NIRS for blood pressure monitoring is innovative, similar studies have shown promise in noninvasive monitoring techniques, but this specific application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts and 1 other locations
- Massachusettes General Hospital — Boston, Massachusetts, United States (RECRUITING)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Emily M Herzberg, MD
- Email: eherzberg@mgh.harvard.edu
- Phone: 617 724 9040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Unstable Blood Pressure, Hypotension, Non-invasive blood pressure monitoring, Arterial Line, NIRS, wearable device, Cerebral oximetry