Actively Recruiting

Phase 3
Age: 1Minute - 6Months
All Genders
ID05648812

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

Age: 1Minute - 6Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Babies less than 7 months treated at the neonatal units of Turku University hospital
Not Eligible

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

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Your Study Journey

Screening

Duration - Up to 7 years recruitment period

Participants are screened for eligibility to participate in the trial.

Screening and enrollment visit

Diagnostic Evaluation

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

Safety Monitoring

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

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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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