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

NCT06994494 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-07-03

No results posted yet for this 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.

Conditions

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Eligibility

Min Age
24 Weeks
Max Age
44 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-09
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06994494 on ClinicalTrials.gov