WithdrawnPhase 3

Preterm Neonates Brain Ultrasound With CEUS and Elastography

Stopped: The recruitment conditions could'n be met, because the clinically based treatment plans were changed before the beginning of recruitment and the ex-preemies didn't have venous access at the time of examinations.

Finland0Started 2024-01-01

Plain-language 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.

Who can participate

Age range

3 Weeks – 6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 day

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

Timeframe: 1 day

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

Timeframe: 1 day

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

Timeframe: 1 day

Trial details

NCT IDNCT05694611

SponsorTurku University Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-01

View on ClinicalTrials.gov More Prematurity trials

Plain-language summary

Who can participate

Age range

3 Weeks – 6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 1 day

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

Timeframe: 1 day

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

Timeframe: 1 day

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

Timeframe: 1 day