Investigating brain perfusion and elasticity in preterm neonates using ultrasound techniques
Contrast Enhanced Ultrasound and Elastography of the Preterm Brain
This study is testing new ultrasound techniques to see how blood flows and the stiffness of the brains of preterm babies at their due date, comparing the results with MRI scans.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 3 Weeks to 6 Months |
| Sex | All |
| Sponsor | Turku University Hospital Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Turku, Southwestern Finland) |
| Trial ID | NCT05694611 on ClinicalTrials.gov |
What this trial studies
This study aims to assess brain perfusion and elasticity in preterm neonates at their estimated due date, comparing the results with magnetic resonance imaging (MRI) findings. Utilizing contrast-enhanced ultrasound (CEUS) with sulphur hexafluoride and ultrasound-assisted elastography, the study will evaluate cerebral hemodynamics in these infants. A total of 100 preterm neonates from the Neonatal Intensive Care Unit (NICU) at Turku University Hospital will be recruited over a potential seven-year period. The ultrasound examinations will be performed alongside clinically scheduled MRI scans, with parental consent obtained prior to participation.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm neonates scheduled for brain MRI at term.
Not a fit: Patients with known genetic diseases, significant congenital malformations, or unstable cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of brain health in preterm infants, leading to improved diagnostic capabilities and treatment strategies.
How similar studies have performed: While the use of CEUS and elastography has been established in Europe and America, this specific application in preterm neonates is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Preterm neonates attending brain MR-imaging at term 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
Where this trial is running
Turku, Southwestern Finland
- Turku University Hospital — Turku, Southwestern Finland, Finland (Recruiting)
Study contacts
- Principal investigator: Tiina Laurikainen — Turku University Hospital
- Study coordinator: Tiina Laurikainen
- Email: tiina.laurikainen@tyks.fi
- Phone: +35823135941
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.