Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2024-01-01
2029-12-31
Brief Summary
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Detailed Description
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Elastography is a method to investigate the elasticity of a tissue by tracking the shear waves generated by the ultrasound beam. Also this method has been used in Europe and America for years.
The aim of our study is to examine cerebral hemodynamics in neonates using ultrasound of the brain, contrast enhanced ultrasound (CEUS) and ultrasound-guided shear-wave elastography (US-SWE). We aim to recruit four groups of infants: those with no suspected diseases affecting brain perfusion on the first days after birth and infants with either asphyctic injury, stroke or other diseases affecting central nervous system. Total recruitment for different groups is 100 infants in total, during this first study phase. The recruitment period will be up to seven years if needed.
The injections of SonoVue will be administered through pre-existing venous cannulas. The first examination after brain injury will be done as soon as the parental consent has been given. The ultrasound examination altogether is estimated to take about 20 minutes per day. Safety monitoring period is conducted after the injection. The studies will be repeated 0-4 times according to the approval of the caretakers of the child and the disease the child is affected by. CEUS data will be analysed with proper software. US-SWE will be measured repeatedly on both brain hemispheres and on different areas to validate the measurements.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Term neonates
Diagnostic 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
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
Sulfur Hexafluoride
To evaluate the differences in brain perfusion studied by CEUS, comparing different patient groups and babies with no suspected brain pathology
Neonatal asphyxia
Diagnostic 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
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
Sulfur Hexafluoride
To evaluate the differences in brain perfusion studied by CEUS, comparing different patient groups and babies with no suspected brain pathology
Neonatal stroke
Diagnostic 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
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
Sulfur Hexafluoride
To evaluate the differences in brain perfusion studied by CEUS, comparing different patient groups and babies with no suspected brain pathology
Other neonatal brain pathologies
Diagnostic 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
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
Sulfur Hexafluoride
To evaluate the differences in brain perfusion studied by CEUS, comparing different patient groups and babies with no suspected brain pathology
Interventions
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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
Sulfur Hexafluoride
To evaluate the differences in brain perfusion studied by CEUS, comparing different patient groups and babies with no suspected brain pathology
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
1 Minute
6 Months
ALL
No
Sponsors
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Turku University Hospital
OTHER_GOV
Responsible Party
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Tiina Laurikainen
Principal Investigator
Principal Investigators
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Tiina Laurikainen
Role: PRINCIPAL_INVESTIGATOR
Turku University Hospital
Riitta Parkkola
Role: STUDY_DIRECTOR
Turku University Hospital
Vilhelmiina Parikka
Role: STUDY_CHAIR
Turku University Hospital
Jussi Hirvonen
Role: STUDY_CHAIR
Turku University Hospital
Locations
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Turku University Hospital
Turku, Southwestern Finland, Finland
Countries
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Central Contacts
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Facility Contacts
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Tiina Laurikainen, MD
Role: primary
Other Identifiers
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TL16102021
Identifier Type: -
Identifier Source: org_study_id
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