Health TrialsbyHealthPanel

Neonatal Brain Ultrasound With CEUS and Elastography

ConditionsNeonatal Hypoxic Ischemic EncephalopathyNeonatal StrokeNeonatal Encephalopathy, Unspecified
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-6
SponsorTurku University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pre-known genetic disease

Difficult congenital malformations that need surgical treatment

Central nervous system tumors

Weight less than 2,5 kg during examination

Trial design

Design model

Parallel

Treatments tested in this trial

  • Brain contrast enhanced ultrasound, brain ultrasound elastography

    Diagnostic test

    To study brain perfusion with brain ultrasound, contrast enhanced ultrasound of the brain and ultrasound-guided shear-wave elastography

  • Sulfur Hexafluoride

    Drug

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

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: Term neonatesActive comparator 2 interventions
Group B: Neonatal asphyxiaExperimental treatment 2 interventions
Group C: Neonatal strokeExperimental treatment 2 interventions
Group D: Other neonatal brain pathologiesExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Repeated qualitative and quantitative assessment of neonatal brain perfusion using contrast-enhanced ultrasound of the brain

Visual assessment of contrast enhancement on both brain hemispheres. Quantitative analysis of proper ultrasound parameters, such as wash-in and wash-out curves, during the adaptive period and during different brain pathologies and their treatment.

Time frame
20 days

Secondary outcomes

1

Repeated qualitative assessment of neonatal brain elasticity using ultrasound-guided shear wave elastography

Quantitative analysis of repeated US-SWE measurements on both hemispheres and areas of interest estimated by brain ultrasound and CEUS

Time frame
20 days
2

Comparing the brain perfusion in neonates with no diseases affecting brain perfusion and neonates with different brain pathologies

Quantitative analysis of proper contrast-enhanced ultrasound parameters, such as wash-in and wash-out curves, in neonates with normal brain perfusion compared to neonates with different brain pathologies.

Time frame
20 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Turku University Hospital

Lead sponsor

Source ClinicalTrials.gov
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