Actively Recruiting
Contrast Enhanced Ultrasound and Elastography of the Neonatal Brain
Led by Turku University Hospital · Updated on 2026-01-15
100
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study changes in brain blood flow and tissue flexibility in newborn babies as they adjust to life outside the womb and during certain illnesses that might affect brain blood flow. The study focuses on newborns treated at Turku University Hospital's Neonatal Units, including those without suspected brain issues and those with conditions like asphyctic injury, stroke, or other brain-related diseases. The goal is to better understand brain circulation using advanced ultrasound techniques. The study uses a special contrast agent called SonoVue (sulfur hexafluoride) to improve ultrasound images of blood vessels and tissue perfusion without radiation or sedation. Ultrasound-guided shear-wave elastography (US-SWE) is also used to measure brain tissue elasticity. The contrast agent is given through existing veins, and ultrasound exams last about 20 minutes per day, repeated up to four times depending on the infant's condition and parental consent. The study includes four groups of infants based on their brain health status. Participants will undergo brain ultrasounds enhanced by contrast and elastography, as well as cardiac ultrasound. Researchers will assess brain blood flow and elasticity repeatedly over about 20 days. Safety monitoring occurs after contrast injections. The study analyzes ultrasound data with specialized software to compare brain perfusion in healthy and affected infants. The total participation period allows for multiple assessments to track changes in brain function and structure.
CONDITIONS
Brief Title
Neonatal Brain Ultrasound With CEUS and Elastography
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Babies less than 7 months treated at the neonatal units of Turku University hospital
You will not qualify if you...
- Pre-known genetic disease
- Difficult congenital malformations that need surgical treatment
- Central nervous system tumors
- Weight less than 2,5 kg during examination
- Medical history of SonoVue hypersensitivity
- Uncontrolled systemic hypertension
- Systolic pulmonary artery pressure > 90 mmHg
- Unstable cardiovascular state
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 7 years recruitment period
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Repeated assessments over approximately 20 days
Participants undergo brain ultrasound, contrast enhanced ultrasound (CEUS), and ultrasound-guided shear-wave elastography to study neonatal brain perfusion and elasticity.
0 to 4 ultrasound examinations depending on caretaker approval and disease condition
Duration - Safety monitoring period following each CEUS injection
Participants are monitored for safety after each injection of the contrast agent SonoVue.
Monitoring visits after each ultrasound examination with contrast injection
Trial Site Locations
Total: 1 location
1
Turku University Hospital
Turku, Southwestern Finland, Finland, 20520
Actively Recruiting
Research Team
T
Tiina Laurikainen
R
Riitta Parkkola
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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