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Recruiting NCT06646250

NCT06646250 NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Circulation Pilot

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Clinical Trial Summary
NCT ID NCT06646250
Status Recruiting
Phase
Sponsor St. Olavs Hospital
Condition Preterm
Study Type OBSERVATIONAL
Enrollment 180 participants
Start Date 2024-10-20
Primary Completion 2028-12-31

Trial Parameters

Condition Preterm
Sponsor St. Olavs Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 180
Sex ALL
Min Age 0 Minutes
Max Age 12 Months
Start Date 2024-10-20
Completion 2028-12-31
Interventions
NeoDoppler - CE certified

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Brief 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 Criteria

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

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