Investigating brain blood flow and elasticity in newborns using ultrasound techniques
Contrast Enhanced Ultrasound and Elastography of the Neonatal Brain
This study is testing a safe ultrasound method to see how blood flows and how stretchy the brain tissue is in newborns, especially those with certain health issues.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 1 Minute to 6 Months |
| Sex | All |
| Sponsor | Turku University Hospital Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Turku, Southwestern Finland) |
| Trial ID | NCT05648812 on ClinicalTrials.gov |
What this trial studies
This study aims to assess brain perfusion and tissue elasticity in neonates adapting to life outside the womb, particularly those with conditions like hypoxic ischemic encephalopathy and stroke. Utilizing contrast-enhanced ultrasound with sulphur hexafluoride and ultrasound-assisted elastography, the research will provide insights into cerebral hemodynamics. The study will recruit a total of 100 infants from the Neonatal Units of Turku University Hospital over a potential seven-year period. The ultrasound examinations will be performed without radiation or sedation, making it a safe approach for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates include infants under 7 months old treated at the neonatal units of Turku University Hospital.
Not a fit: Patients with known genetic diseases, severe congenital malformations, or unstable cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic capabilities for neonatal brain conditions, leading to better management and outcomes for affected infants.
How similar studies have performed: While the use of ultrasound techniques in neonates is established, this specific combination of contrast-enhanced ultrasound and elastography for assessing brain conditions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
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.