Neonatal Brain Ultrasound With CEUS and Elastography
Contrast Enhanced Ultrasound and Elastography of the Neonatal Brain
1 other identifier
interventional
100
1 country
1
Brief Summary
The aim of our study is to investigate changes of brain perfusion and elasticity in neonates during the time that a neonate is adapting to live outside the womb and during diseases that are suspected to affect neonatal brain perfusion. We use contrast enhanced ultrasound (sulphur hexafluoride) and ultrasound-assisted elastography to evaluate the state of brain perfusion. We will study neonates recruited from the Neonatal Units of Turku University Hospital.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2024
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2022
CompletedFirst Posted
Study publicly available on registry
December 13, 2022
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
January 15, 2026
January 1, 2026
5.5 years
December 5, 2022
January 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Repeated qualitative and quantitative assessment of neonatal brain perfusion using contrast-enhanced ultrasound of the brain
Visual assessment of contrast enhancement on both brain hemispheres. Quantitative analysis of proper ultrasound parameters, such as wash-in and wash-out curves, during the adaptive period and during different brain pathologies and their treatment.
20 days
Secondary Outcomes (2)
Repeated qualitative assessment of neonatal brain elasticity using ultrasound-guided shear wave elastography
20 days
Comparing the brain perfusion in neonates with no diseases affecting brain perfusion and neonates with different brain pathologies
20 days
Study Arms (4)
Term neonates
ACTIVE COMPARATORDiagnostic Test: Brain ultrasound, brain contrast enhanced ultrasound, brain ultrasound elastography, cardiac ultrasound To study brain perfusion with brain ultrasound, contrast enhanced ultrasound of the brain and ultrasound-guided shear-wave elastography Drug: Sulfur Hexafluoride To evaluate brain perfusion in infants with no suspected brain pathology using CEUS. Later, different patient groups could be compared to infants with no suspected brain pathology. Other Names: • SonoVue
Neonatal asphyxia
EXPERIMENTALDiagnostic Test: Brain ultrasound, brain contrast enhanced ultrasound, brain ultrasound elastography To study brain perfusion with brain ultrasound, contrast enhanced ultrasound of the brain and ultrasound-guided shear-wave elastography Drug: Sulfur Hexafluoride To evaluate brain perfusion in neonates after birth asphyxia Other Names: • SonoVue
Neonatal stroke
EXPERIMENTALDiagnostic Test: Brain contrast enhanced ultrasound, brain ultrasound elastography To study brain perfusion with brain ultrasound, contrast enhanced ultrasound of the brain and ultrasound-guided shear-wave elastography Drug: Sulfur Hexafluoride To evaluate brain perfusion after neonatal stroke Other Names: • SonoVue
Other neonatal brain pathologies
EXPERIMENTALDiagnostic Test: Brain ultrasound, brain contrast enhanced ultrasound, brain ultrasound elastography To study brain perfusion with brain ultrasound, contrast enhanced ultrasound of the brain and ultrasound-guided shear-wave elastography Drug: Sulfur Hexafluoride To evaluate brain perfusion in infants with other type (no asphyxia, stroke or preterm birth related) of brain pathology, like hydrocephalus, hemorrhage or central nervous system infection Other Names: • SonoVue
Interventions
To study brain perfusion with brain ultrasound, contrast enhanced ultrasound of the brain and ultrasound-guided shear-wave elastography
To evaluate the differences in brain perfusion studied by CEUS, comparing different patient groups and babies with no suspected brain pathology
Eligibility Criteria
You may qualify if:
- Babies less than 7 months treated at the neonatal units of Turku University hospital
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Turku University Hospital
Turku, Southwestern Finland, 20520, Finland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tiina Laurikainen
Turku University Hospital
- STUDY DIRECTOR
Riitta Parkkola
Turku University Hospital
- STUDY CHAIR
Vilhelmiina Parikka
Turku University Hospital
- STUDY CHAIR
Jussi Hirvonen
Turku University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 5, 2022
First Posted
December 13, 2022
Study Start
January 1, 2024
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
January 15, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share