RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-09
Study Completion:2026-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06994494

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:24 Weeks to 44 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Neonates ≥24 \& \<44 weeks postmenstrual age
  2. * Hospitalization in MGH or BWH newborn service units
  3. * For A-line BP monitoring: Neonates expected to maintain A-line monitoring for at least the next 12 hours
  4. * 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
  1. * Contraindication to FlexNIRS device placement on the scalp/head
  2. * Underlying congenital/genetic anomalies

Contacts and Locations

Study Contact

Emily M Herzberg, MD
CONTACT
617 724 9040
eherzberg@mgh.harvard.edu
Mohamed A El-Dib, MD
CONTACT
617-732-6902
mel-dib@bwh.harvard.edu

Study Locations (Sites)

Massachusettes General Hospital
Boston, Massachusetts, 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-09
Study Completion Date2026-11-30

Study Record Updates

Study Start Date2025-04-09
Study Completion Date2026-11-30

Terms related to this study

Keywords Provided by Researchers

  • Non-invasive blood pressure monitoring
  • Arterial Line
  • NIRS
  • wearable device
  • Cerebral oximetry

Additional Relevant MeSH Terms

  • Unstable Blood Pressure
  • Hypotension