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NCT06994494 · ClinicalTrials.gov registry record
Noninvasive Continuous BP Monitoring in Newborns Based on Pulsatile Signal Morphological Features Using NIRS
A clinical trial of Hypotension and Unstable Blood Pressure, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- 80
- Enrollment target
- 2
- Study locations
NCT06994494: Recruiting study of Hypotension and Unstable Blood Pressure, sponsored by Massachusetts General Hospital.
NCT06994494 is a study of Hypotension and Unstable Blood Pressure that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 80 participants, roughly in line with the 74-participant average among 12 other Hypotension trials with a reported enrollment target. The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06994494, a study of Hypotension and Unstable Blood Pressure, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- 80 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Determine the correlation between FlexNIRS based blood pressure estimation and invasive A-line blood pressure as the gold standard or periodic BP cuff readings performed by clinical staff.
Conditions Studied
Study Locations (2)
Massachusetts
- Massachusettes General Hospital - Boston
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-04-09 |
| Est. Completion | 2026-11-30 |
What NCT06994494 shows while recruiting
NCT06994494 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target, roughly in line with the 74-participant average among 12 other Hypotension trials with a reported enrollment target.
The record links to 2 conditions, with Hypotension appearing as the primary indexed condition, and to 0 interventions.
NCT06994494 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06994494 about?
NCT06994494 is a clinical study titled "Noninvasive Continuous BP Monitoring in Newborns Based on Pulsatile Signal Morphological Features Using NIRS". 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 standar...
What is the current status of trial NCT06994494?
This trial is currently recruiting. The enrollment target is 80 participants. The study started on 2025-04-09. Estimated completion is 2026-11-30.
What conditions does trial NCT06994494 study?
This clinical trial studies the following conditions: Hypotension, Unstable Blood Pressure.
Who is sponsoring clinical trial NCT06994494?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06994494 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06994494's enrollment target sits among peer trials
80 5th of 12 higher than 8 of 12 other Hypotension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypotension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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