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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-12
SponsorSt. Olavs Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Open fontanelle

Healthy preterm or term born neonates

Neonates with a medical condition of interest according to the different cohort studies: patent ductus arteriosus, perinatal asphyxia, stroke, pulmonary hypertension, congenital heart condition or infection/sepsis/meningitis

Neonates in need of procedures

Disqualifiers

Caregivers not understanding/speaking Norwegian or English

Caregivers not giving their consent

Trial population

Neonates/infants born prematurely or at term that are healthy or that have a medical contentions or that are in need of procedures that are admitted to the maternal ward or neonatal intensive care at St. Olavs Hospital in Trondheim, Norway.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • NeoDoppler - CE certified

    Device

    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.

Treatment groups

180 Participants
are divided into 5 treatment groups
Group A: Feasibility study - Healthy neonates1 intervention
Group B: Patients with patent ductus arteriosus (premature infants)1 intervention
Group C: Different groups of sick neonates1 intervention
Group D: Neonates/infants undergoing procedures1 intervention
Group E: Neonates with infection/sepsis1 intervention

Trial outcomes

Primary outcomes

1

Cerebral Doppler velocities (cm/second)

Cerebral Doppler velocities measured in cm/sec is generated by tracing of the Doppler spectrum.

Time frame
2 hours - 7 days

Secondary outcomes

1

Measurement quality

Quality indicator: Defined as a scale from 0-100% where 100% is the best possible Doppler spectrum quality. Values below 80% is below the threshold of good enough quality to be used as valid measurements in the study.

Time frame
2 hours - 7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Olavs Hospital

Lead sponsor

Norwegian University of Science and Technology

Collaborator