Clinical trial NCT05648812: Neonatal Brain Ultrasound With CEUS and Elastography
Official title: Contrast Enhanced Ultrasound and Elastography of the Neonatal Brain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Neonatal Hypoxic Ischemic Encephalopathy
Neonatal Stroke
Neonatal Encephalopathy, Unspecified
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2022-12-13
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 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.

Eligibility criteria: Inclusion Criteria:

* Babies less than 7 months treated at the neonatal units of Turku University hospital

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: Repeated qualitative and quantitative assessment of neonatal brain perfusion using contrast-enhanced ultrasound of the brain
timeFrame: 20 days
Secondary outcomes:
measure: Repeated qualitative assessment of neonatal brain elasticity using ultrasound-guided shear wave elastography
timeFrame: 20 days
measure: Comparing the brain perfusion in neonates with no diseases affecting brain perfusion and neonates with different brain pathologies
timeFrame: 20 days
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
References: