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NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Circulation Pilot

NCT06646250 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2026-04-23

No results posted yet for this study

Summary

Non-invasive tools for monitoring of course of disease are important and necessary in the treatment of pre-term/premature infants and sick neonates. For many years, the ultrasound group in Trondheim has been at the forefront in the development of new ultrasound technology for the diagnosis and monitoring of disease. Several methods previously developed in this research group are today widely used in hospitals around the world. In this project the investigators aim to test a new ultrasound technology that allows continuous monitoring of cerebral blood flow in sick neonates and pre-term children. This technology was CE-certified in October 2022, and in this project the investigators will test the CE-certified version with the newest available approved software.

Conditions

Interventions

DEVICE

NeoDoppler - CE certified

The NeoDoppler is small and light weighed constructed as a single element transducer, that can be gently fixed over the fontanelle. The system is fully compatible for cooccurring use with other intensive care equipment for neonates as well as caregiving from the parents. It is capable of measuring cerebral blood flow at different depths of the brain simultaneously. The Doppler velocity measurements arise from a cylindrical volume of tissue. It is therefore less sensitive to the exact position and angle of the probe over the fontanel to target the vessels of interest than standard hand-held Doppler. This means that the NeoDoppler system may be placed by healthcare professionals who do not have specialized training performing diagnostic ultrasound exams of the cerebral vasculature in neonates.

Sponsors & Collaborators

  • Norwegian University of Science and Technology

    collaborator OTHER

  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Siri Ann Nyrnes, MD, PhD · Childrens Clinic, St. Olavs University Hospital and NTNU

  • Øyvind Rognmo, PhD · Norwegian University of Science and Technology, Trondheim, Norway

Eligibility

Min Age
0 Minutes
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-20
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • Norway

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 NCT06646250 on ClinicalTrials.gov