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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 1
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Norway
Children's clinic, St. Olavs University Hospital
RECRUITING
Trondheim
Contact Information
Primary
Siri Ann Nyrnes, MD, PhD
siri.a.nyrnes@ntnu.no
004793062121
Backup
Siv Steinsmo Ødegård, MD, PhD
siv.steinsmo@gmail.com
97772989
Time Frame
Start Date: 2024-10-20
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 180
Treatments
Feasibility study - Healthy neonates
Neonates born with gestational week \< 32 weeks, gestational week 32-37 and at term. Will will include 20-30 of each sex in each group.
Patients with patent ductus arteriosus (premature infants)
Preterm neonates with patent ductus arteriosus (n=20)
Different groups of sick neonates
Neonates with different medical conditions such as perinatal asphyxia, stroke, pulmonary hypertension and congenital heart disease will be conducted. We will include 5-30 neonates in each group.
Neonates/infants undergoing procedures
Neonates/infants undergoing procedures such as intubation, anesthesia, spinal puncture, peripheral and central arterial and venous catheter. We will include 20-30 neonates.
Neonates with infection/sepsis
Infants with infection/sepsis and/or meningitis (n=40).
Sponsors
Leads: St. Olavs Hospital
Collaborators: Norwegian University of Science and Technology

This content was sourced from clinicaltrials.gov