Preterm Neonates Brain Ultrasound With CEUS and Elastography

NCT05694611 | Withdrawn Phase 3

• 1 other identifier: TL16102021.1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate levels of brain perfusion and elasticity in preterm neonates when they reach the estimated due date and to compare the data with magnetic resonance imaging at term. Contrast enhanced ultrasound (sulphur hexafluoride) and ultrasound-assisted elastography will be used to evaluate the state of brain perfusion with ultrasound. Different appropriate imaging sequences will be used regarding MRI, including asl-perfusion. Neonates recruited from the Neonatal Intensive Care Unit (NICU) of Turku University Hospital will be recruited.

Conditions

Prematurity

Outcome Measures

Primary Outcomes (4)

• Quantitative assessment of neonatal brain perfusion using calculated time-intensity curve of enhancement in brain CEUS at term

  Quantitative analysis will be executed from a time-intensity curve generated from a region of interest and from left and right talami. Wash-in slope and wash-out slope (measured in echo power units per second) will be measured and compared on healthy versus diseased preterm neonates at term.

  1 day

• Quantitative assessment of neonatal brain peak enhancement using calculated time-intensity curve of enhancement in brain CEUS at term

  Quantitative analysis will be executed from a time-intensity curve generated from a region of interest and from left and right talami. Peak enhancement will be measured as maximum echo power on time-intensity curve.

  1 day

• Quantitative assessment of neonatal brain perfusion time to peak using calculated time-intensity curve of enhancement in brain CEUS at term

  Quantitative analysis will be executed from a time-intensity curve generated from a region of interest and from left and right talami. Time to peak will be measured in seconds in time-intensity curve.

  1 day

• Quantitative assessment of neonatal brain perfusion volume using calculated time-intensity curve of enhancement in brain CEUS at term

  Quantitative analysis will be executed from a time-intensity curve generated from a region of interest and from left and right talami. Area under the curve reporting total enhancement volume from time-intensity curve.

  1 day

Secondary Outcomes (2)

• Neonatal brain perfusion assessed with time-intensity curves of contrast enhanced ultrasound compared with brain magnetic resonance asl perfusion imaging

  1 day

• Qualitative assessment of neonatal brain elasticity using ultrasound-guided shear wave elastography

  1 day

Study Arms (1)

Preterm neonates

EXPERIMENTAL

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 at term in infants born prematurely Other Names: • SonoVue

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

Interventions

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

Preterm neonates

Sulfur Hexafluoride DRUG

To evaluate the differences in brain perfusion and elasticity studied by CEUS and shear-wave elastography, comparing term neonates with and without MRI verified brain pathologies and to compare the ultrasound CEUS and elastography data to MRI.

Also known as: SonoVue

Preterm neonates

Eligibility Criteria

• Age: 3 Weeks - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm neonates attending brain MR-imaging at term

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku University Hospital

Turku, Southwestern Finland, 20520, Finland

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Sulfur Hexafluoride; contrast agent BR1

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Gases; Sulfur Compounds

Study Officials

• Tiina Laurikainen

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

• Riitta Parkkola

  Turku University Hospital

  STUDY DIRECTOR

• Vilhelmiina Parikka

  Turku University Hospital

  STUDY CHAIR

• Jussi Hirvonen

  Turku University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: January 23, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)