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RECRUITINGOBSERVATIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - Caregivers not understanding/speaking Norwegian or English - Caregivers not giving their consent Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Exclusion Criteria: * Caregivers not understanding/speaking Norwegian or English * Caregivers not giving their consent

Treatments Being Tested

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.

Locations (1)

Children's clinic, St. Olavs University Hospital
Trondheim, Norway