Neonatal Brain Ultrasound With CEUS and Elastography

Turku University Hospital (TYKS)

Status and phase: Enrolling; Phase 3

Conditions: Neonatal Hypoxic Ischemic Encephalopathy; Neonatal Encephalopathy, Unspecified; Neonatal Stroke

Treatments: Drug: Sulfur Hexafluoride; Diagnostic Test: Brain contrast enhanced ultrasound, brain ultrasound elastography

Study type: Interventional

Funder types: Other

Identifiers

NCT05648812

TL16102021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 minute to 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Term neonates

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Brain contrast enhanced ultrasound, brain ultrasound elastography

Drug: Sulfur Hexafluoride

Neonatal asphyxia

Experimental group

Description:

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

Treatment:

Diagnostic Test: Brain contrast enhanced ultrasound, brain ultrasound elastography

Drug: Sulfur Hexafluoride

Neonatal stroke

Experimental group

Description:

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

Treatment:

Diagnostic Test: Brain contrast enhanced ultrasound, brain ultrasound elastography

Drug: Sulfur Hexafluoride

Other neonatal brain pathologies

Experimental group

Description:

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

Treatment:

Diagnostic Test: Brain contrast enhanced ultrasound, brain ultrasound elastography

Drug: Sulfur Hexafluoride