RecruitingNCT06646250

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

NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Blood Flow in Infants

Sponsor

St. Olavs Hospital

Enrollment

180 participants

Start Date

Oct 20, 2024

Study Type

OBSERVATIONAL

Conditions

Sepsis Stroke Pulmonary Hypertension Congenital Heart Disease Preterm Patent Ductus Arteriosus Asphyxia

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.

Eligibility

Min Age: 0 MinutesMax Age: 12 Months

Plain Language Summary

Simplified for easier understanding

This pilot study is testing a new ultrasound technology called NeoDoppler to continuously monitor blood flow to the brain in newborn babies. The goal is to see if this device can detect changes in circulation that may signal brain problems in sick or premature babies. **You may be eligible if...** - Your baby is a newborn (preterm or full-term) with an open fontanelle (the soft spot on the head) - Your baby is either healthy or has a medical condition such as a heart problem, patent ductus arteriosus, birth asphyxia, stroke, pulmonary hypertension, or infection/sepsis/meningitis - Your baby needs a medical procedure where brain blood flow monitoring would be useful **You may NOT be eligible if...** - The baby's caregivers do not speak Norwegian or English - The baby's caregivers do not provide consent to participate Talk to your doctor or baby's care team to see if this trial is right for your child.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENeoDoppler - 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.