Noninvasive blood pressure monitoring in newborns using a new device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.