PrematurityPhase 3NCT05694611
Preterm Neonates Brain Ultrasound With CEUS and Elastography
A Phase 3 study testing Brain contrast enhanced ultrasound, brain ultrasound elastography and Sulfur Hexafluoride in people with Prematurity, run by Turku University Hospital at 1 site in Finland.
Trial summary
The aim of the study is to investigate levels of brain perfusion and elasticity in preterm neonates when they reach the estimated due date and to compare the data with magnetic resonance imaging at term. Read more about this study
- Who is it for?
- Ages 3 weeks to 6 months
- Conditions the study is for
- Prematurity
- What is being tested?
- Brain contrast enhanced ultrasound, brain ultrasound elastography and Sulfur Hexafluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2024to Jan 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 weeks to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm neonates attending brain MR-imaging at term
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contrast Enhanced Ultrasound and Elastography of the Preterm Brain
The aim of the study is to investigate levels of brain perfusion and elasticity in preterm neonates when they reach the estimated due date and to compare the data with magnetic resonance imaging at term. Contrast enhanced ultrasound (sulphur hexafluoride) and ultrasound-assisted elastography will be used to evaluate the state of brain perfusion with ultrasound. Different appropriate imaging sequences will be used regarding MRI, including asl-perfusion. Neonates recruited from the Neonatal Intensive Care Unit (NICU) of Turku University Hospital will be recruited.
Read the detailed description
SonoVue (sulphur hexafluoride) is a contrast agent composed of micro bubbles. It increases echogenicity of the ultrasound thus enhancing the visualisation of vessels and giving better insights into tissue perfusion. The use of sulphur hexafluoride has been approved by FDA and it has been in off-label use in Europe for years. SonoVue is thought to be especially useful for children, because it can enhance the diagnostic capabilities of ultrasound and the examination can be performed without radiation or sedation.
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 this study is to examine cerebral hemodynamics in preterm neonates reaching term age, using ultrasound of the brain, contrast enhanced ultrasound (CEUS) and ultrasound-guided shear-wave elastography (US-SWE). The brain ultrasound, CEUS and US-SWE to preterm babies is planned to take place while having a clinically appointed brain magnetic resonance imaging at about term. Total recruitment for the study is 100 infants in total. The recruitment period will be up to seven years if needed.
The injections of SonoVue will be administered through pre-existing venous cannulas. The examination will be done in addition to the MR-imaging, after 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. 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. Ultrasound data will be evaluated comparing preterm neonates with and without MRI-proven brain pathology and comparing the ultrasound-achieved data to magnetic resonance imaging.
- Conditions
- Prematurity
- Being tested
- Brain contrast enhanced ultrasound, brain ultrasound elastography, Sulfur Hexafluoride
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain contrast enhanced ultrasound, brain ultrasound elastographyDiagnostic test
To study brain perfusion with brain ultrasound, contrast enhanced ultrasound of the brain and ultrasound-guided shear-wave elastography
Sulfur HexafluorideDrug
Also called SonoVue
To evaluate the differences in brain perfusion and elasticity studied by CEUS and shear-wave elastography, comparing term neonates with and without MRI verified brain pathologies and to compare the ultrasound CEUS and elastography data to MRI.
| Study group | Role | What they receive |
|---|---|---|
| Preterm neonates | Experimental | 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 at term in infants born prematurely
Other Names:
• SonoVue Receives: Diagnostic Test: Brain contrast enhanced ultrasound, brain ultrasound elastography; Drug: Sulfur Hexafluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative assessment of neonatal brain perfusion using calculated time-intensity curve of enhancement in brain CEUS at term
Quantitative analysis will be executed from a time-intensity curve generated from a region of interest and from left and right talami. Wash-in slope and wash-out slope (measured in echo power units per second) will be measured and compared on healthy versus diseased preterm neonates at term.
Measured: 1 day
Quantitative assessment of neonatal brain peak enhancement using calculated time-intensity curve of enhancement in brain CEUS at term
Quantitative analysis will be executed from a time-intensity curve generated from a region of interest and from left and right talami. Peak enhancement will be measured as maximum echo power on time-intensity curve.
Measured: 1 day
Quantitative assessment of neonatal brain perfusion time to peak using calculated time-intensity curve of enhancement in brain CEUS at term
Quantitative analysis will be executed from a time-intensity curve generated from a region of interest and from left and right talami. Time to peak will be measured in seconds in time-intensity curve.
Measured: 1 day
Quantitative assessment of neonatal brain perfusion volume using calculated time-intensity curve of enhancement in brain CEUS at term
Quantitative analysis will be executed from a time-intensity curve generated from a region of interest and from left and right talami. Area under the curve reporting total enhancement volume from time-intensity curve.
Measured: 1 day
Secondary outcomes (2)
Neonatal brain perfusion assessed with time-intensity curves of contrast enhanced ultrasound compared with brain magnetic resonance asl perfusion imaging
Time-intensity curves of CEUS and MRI ASL-perfusion studies will be performed comparing time to peak, peak enhancement, wash-in and wash-out curves and mean transit times on different imaging methods. Assessment will be done in correlation with clinical information.
Measured: 1 day
Qualitative assessment of neonatal brain elasticity using ultrasound-guided shear wave elastography
Quantitative analysis of repeated US-SWE measurements on both hemispheres of thalami and areas of interest estimated by brain ultrasound and elastography. Tissue elasticity will be reported in kilopascals, comparing the findings of thalami and regions of interest on the left and on the right.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start1 Jan 2024
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Why it stopped: The recruitment conditions could'n be met, because the clinically based treatment plans were changed before the beginning of recruitment and the ex-preemies didn't have venous access at the time of examinations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tiina Laurikainen, Turku University Hospital
- Investigators
- Tiina Laurikainen, Principal investigator, Turku University HospitalRiitta Parkkola, Study director, Turku University HospitalVilhelmiina Parikka, Study chair, Turku University HospitalJussi Hirvonen, Study chair, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694611
- Sponsor's protocol ID
- TL16102021.1
- Status last verified
- Jan 2026
- First submitted
- 5 Dec 2022
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhanced Ultrasound and Elastography of the Preterm Brain
- ClinicalTrials.gov ID
- NCT05694611
- Acronym / sponsor ID
- TL16102021.1
- Conditions
- Prematurity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The recruitment conditions could'n be met, because the clinically based treatment plans were changed before the beginning of recruitment and the ex-preemies didn't have venous access at the time of examinations.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate levels of brain perfusion and elasticity in preterm neonates when they reach the estimated due date and to compare the data with magnetic resonance imaging at term. Contrast enhanced ultrasound (sulphur hexafluoride) and ultrasound-assisted elastography will be used to evaluate the state of brain perfusion with ultrasound. Different appropriate imaging sequences will be used regarding MRI, including asl-perfusion. Neonates recruited from the Neonatal Intensive Care Unit (NICU) of Turku University Hospital will be recruited.
Detailed description
SonoVue (sulphur hexafluoride) is a contrast agent composed of micro bubbles. It increases echogenicity of the ultrasound thus enhancing the visualisation of vessels and giving better insights into tissue perfusion. The use of sulphur hexafluoride has been approved by FDA and it has been in off-label use in Europe for years. SonoVue is thought to be especially useful for children, because it can enhance the diagnostic capabilities of ultrasound and the examination can be performed without radiation or sedation.
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 this study is to examine cerebral hemodynamics in preterm neonates reaching term age, using ultrasound of the brain, contrast enhanced ultrasound (CEUS) and ultrasound-guided shear-wave elastography (US-SWE). The brain ultrasound, CEUS and US-SWE to preterm babies is planned to take place while having a clinically appointed brain magnetic resonance imaging at about term. Total recruitment for the study is 100 infants in total. The recruitment period will be up to seven years if needed.
The injections of SonoVue will be administered through pre-existing venous cannulas. The examination will be done in addition to the MR-imaging, after 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. 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. Ultrasound data will be evaluated comparing preterm neonates with and without MRI-proven brain pathology and comparing the ultrasound-achieved data to magnetic resonance imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm neonates | Experimental | Diagnostic Test: Brain contrast enhanced ultrasound, brain ultrasound elastography, Drug: Sulfur HexafluorideDiagnostic 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 at term in infants born prematurely Other Names: • SonoVue |
Who may qualify
- Ages
- 3 weeks to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm neonates attending brain MR-imaging at term
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain contrast enhanced ultrasound, brain ultrasound elastographyTo study brain perfusion with brain ultrasound, contrast enhanced ultrasound of the brain and ultrasound-guided shear-wave elastography | Diagnostic test | Preterm neonates |
| Sulfur HexafluorideAlso: SonoVueTo evaluate the differences in brain perfusion and elasticity studied by CEUS and shear-wave elastography, comparing term neonates with and without MRI verified brain pathologies and to compare the ultrasound CEUS and elastography data to MRI. | Drug | Preterm neonates |
Primary outcome
Quantitative assessment of neonatal brain perfusion using calculated time-intensity curve of enhancement in brain CEUS at term
Time frame: 1 day
Quantitative analysis will be executed from a time-intensity curve generated from a region of interest and from left and right talami. Wash-in slope and wash-out slope (measured in echo power units per second) will be measured and compared on healthy versus diseased preterm neonates at term.
Quantitative assessment of neonatal brain peak enhancement using calculated time-intensity curve of enhancement in brain CEUS at term
Time frame: 1 day
Quantitative analysis will be executed from a time-intensity curve generated from a region of interest and from left and right talami. Peak enhancement will be measured as maximum echo power on time-intensity curve.
Quantitative assessment of neonatal brain perfusion time to peak using calculated time-intensity curve of enhancement in brain CEUS at term
Time frame: 1 day
Quantitative analysis will be executed from a time-intensity curve generated from a region of interest and from left and right talami. Time to peak will be measured in seconds in time-intensity curve.
Quantitative assessment of neonatal brain perfusion volume using calculated time-intensity curve of enhancement in brain CEUS at term
Time frame: 1 day
Quantitative analysis will be executed from a time-intensity curve generated from a region of interest and from left and right talami. Area under the curve reporting total enhancement volume from time-intensity curve.
2 secondary outcomes
Neonatal brain perfusion assessed with time-intensity curves of contrast enhanced ultrasound compared with brain magnetic resonance asl perfusion imaging
Time frame: 1 day
Qualitative assessment of neonatal brain elasticity using ultrasound-guided shear wave elastography
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiina Laurikainen principal investigator
Turku University Hospital
Riitta Parkkola study director
Turku University Hospital
Vilhelmiina Parikka study chair
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brain contrast enhanced ultrasound, brain ultrasound elastography and Sulfur Hexafluoride in people with Prematurity, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative assessment of neonatal brain perfusion using calculated time-intensity curve of enhancement in brain CEUS at term (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.