Clinical trial NCT05694611: Preterm Neonates Brain Ultrasound With CEUS and Elastography
Official title: Contrast Enhanced Ultrasound and Elastography of the Preterm Brain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prematurity
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2023-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Preterm neonates attending brain MR-imaging at term

Exclusion Criteria:

* 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

Primary outcomes:
measure: Quantitative assessment of neonatal brain perfusion using calculated time-intensity curve of enhancement in brain CEUS at term
timeFrame: 1 day
measure: Quantitative assessment of neonatal brain peak enhancement using calculated time-intensity curve of enhancement in brain CEUS at term
timeFrame: 1 day
measure: Quantitative assessment of neonatal brain perfusion time to peak using calculated time-intensity curve of enhancement in brain CEUS at term
timeFrame: 1 day
measure: Quantitative assessment of neonatal brain perfusion volume using calculated time-intensity curve of enhancement in brain CEUS at term
timeFrame: 1 day
Secondary outcomes:
measure: Neonatal brain perfusion assessed with time-intensity curves of contrast enhanced ultrasound compared with brain magnetic resonance asl perfusion imaging
timeFrame: 1 day
measure: Qualitative assessment of neonatal brain elasticity using ultrasound-guided shear wave elastography
timeFrame: 1 day
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
state: Southwestern Finland
Study officials:
affiliation: Turku University Hospital
name: Tiina Laurikainen
role: PRINCIPAL_INVESTIGATOR
affiliation: Turku University Hospital
name: Riitta Parkkola
role: STUDY_DIRECTOR
affiliation: Turku University Hospital
name: Vilhelmiina Parikka
role: STUDY_CHAIR
affiliation: Turku University Hospital
name: Jussi Hirvonen
role: STUDY_CHAIR
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