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

Sponsor
St. Olavs Hospital
Study ID
NCT06646250
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
0 Minutes - 12 Months
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Oct 17, 2024
Start date
Oct 20, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
180 participants (estimated)

Arms

  • Arm: 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.
  • Arm: Patients with patent ductus arteriosus (premature infants)
    Preterm neonates with patent ductus arteriosus (n=20)
  • Arm: 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.
  • Arm: 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.
  • Arm: Neonates with infection/sepsis
    Infants with infection/sepsis and/or meningitis (n=40).

Primary Outcome Measure

Cerebral Doppler velocities (cm/second) [ Time Frame: 2 hours - 7 days ]

Central Contacts

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