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Neonatal Brain Ultrasound With CEUS and Elastography

Primary Purpose

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

Status
Not yet recruiting
Phase
Phase 3
Locations
Finland
Study Type
Interventional
Intervention
Brain contrast enhanced ultrasound, brain ultrasound elastography
Sulfur Hexafluoride
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neonatal Hypoxic Ischemic Encephalopathy

Eligibility Criteria

1 Minute - 6 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Term neonates

Neonatal asphyxia

Neonatal stroke

Other neonatal brain pathologies

Arm 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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
December 5, 2022
Last Updated
April 24, 2023
Sponsor
Turku University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05648812
Brief Title
Neonatal Brain Ultrasound With CEUS and Elastography
Official Title
Contrast Enhanced Ultrasound and Elastography of the Neonatal Brain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
July 2029 (Anticipated)
Study Completion Date
December 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Hypoxic Ischemic Encephalopathy, Neonatal Stroke, Neonatal Encephalopathy, Unspecified

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Term neonates
Arm Type
Active Comparator
Arm 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
Arm Title
Neonatal asphyxia
Arm Type
Experimental
Arm 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
Arm Title
Neonatal stroke
Arm Type
Experimental
Arm 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
Arm Title
Other neonatal brain pathologies
Arm Type
Experimental
Arm 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
Intervention Type
Diagnostic Test
Intervention Name(s)
Brain contrast enhanced ultrasound, brain ultrasound elastography
Intervention Description
To study brain perfusion with brain ultrasound, contrast enhanced ultrasound of the brain and ultrasound-guided shear-wave elastography
Intervention Type
Drug
Intervention Name(s)
Sulfur Hexafluoride
Other Intervention Name(s)
SonoVue
Intervention Description
To evaluate the differences in brain perfusion studied by CEUS, comparing different patient groups and babies with no suspected brain pathology
Primary Outcome Measure Information:
Title
Repeated qualitative and quantitative assessment of neonatal brain perfusion using contrast-enhanced ultrasound of the brain
Description
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 Outcome Measure Information:
Title
Repeated qualitative assessment of neonatal brain elasticity using ultrasound-guided shear wave elastography
Description
Quantitative analysis of repeated US-SWE measurements on both hemispheres and areas of interest estimated by brain ultrasound and CEUS
Time Frame
20 days
Title
Comparing the brain perfusion in neonates with no diseases affecting brain perfusion and neonates with different brain pathologies
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiina Laurikainen
Phone
+35823135941
Email
tiina.laurikainen@tyks.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Riitta Parkkola
Phone
+35823130148
Email
riitta.parkkola@tyks.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiina Laurikainen
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Riitta Parkkola
Organizational Affiliation
Turku University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Vilhelmiina Parikka
Organizational Affiliation
Turku University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jussi Hirvonen
Organizational Affiliation
Turku University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Turku University Hospital
City
Turku
State/Province
Southwestern Finland
ZIP/Postal Code
20520
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

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Neonatal Brain Ultrasound With CEUS and Elastography

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