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Clinical trial

Contrast Enhanced Ultrasound and Elastography of the Neonatal Brain

ID
Name
TL16102021
Description
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.
Trial arms
Trial start
2023-05-01
Estimated PCD
2029-07-01
Trial end
2029-12-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
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
Arms:
Neonatal asphyxia, Neonatal stroke, Other neonatal brain pathologies, Term neonates
Sulfur Hexafluoride
To evaluate the differences in brain perfusion studied by CEUS, comparing different patient groups and babies with no suspected brain pathology
Arms:
Neonatal asphyxia, Neonatal stroke, Other neonatal brain pathologies, Term neonates
Other names:
SonoVue
Size
100
Primary endpoint
Repeated qualitative and quantitative assessment of neonatal brain perfusion using contrast-enhanced ultrasound of the brain
20 days
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-04-25

1 organization

1 product

4 indications

Organization
Turku University Hospital
Product
Sulfur Hexafluoride
Indication
Neonatal Hypoxic Ischemic Encephalopathy
Indication
Neonatal Stroke
Indication
Neonatal Encephalopathy
Indication
Unspecified