NCT05648812

Neonatal Brain Ultrasound With CEUS and Elastography

Contrast Enhanced Ultrasound and Elastography of the Neonatal Brain

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Turku University Hospital · Other Government
• Sex: All
• Age: 1 Minute – 6 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Neonatal Hypoxic Ischemic Encephalopathy
• Neonatal Stroke
• Neonatal Encephalopathy, Unspecified

Interventions

Type	Name	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 the differences in brain perfusion studied by CEUS, comparing different patient groups and babies with no suspected brain pathology

Timeline

• Start date: 2024-01-01
• Primary completion: 2029-07-01
• Completion: 2029-12-01
• First posted: 2022-12-13
• Last updated: 2026-01-15

Locations

1 site across 1 country: Finland