NIRS Device for Blood Pressure Monitoring in Newborns
Noninvasive Continuous BP Monitoring in Newborns Based on Pulsatile Signal Morphological Features Using NIRS
Recruiting
Observational Study
Unstable Blood Pressure
Hypotension
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 24 Weeks – 44 Weeks
- Sex
- Any
- Study type
- Observational
- Participants needed
- 80 (estimated)
- Sponsor
- Massachusetts General Hospital · Other
Who this trial is looking for
This trial is looking for newborns at risk for unstable blood pressure to test a new device that can measure blood pressure without needles. Participants will wear a small sensor on their forehead during their hospital stay.
Are You a Good Fit for This Trial?
You may be able to join if
- I am a newborn aged 24 to 44 weeks postmenstrual age.
- I am hospitalized in the MGH or BWH newborn service units.
- I will need an arterial line for at least the next 12 hours.
- I am at risk for unstable blood pressure and can receive cuff blood pressure monitoring.
You may not be able to join if
- I cannot have the FlexNIRS device placed on my scalp or head.
- I have congenital or genetic anomalies.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
About This Trial
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 infan…
Trial Locations
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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 pressu…
Contacts