SafeBoosC III Two-year Follow-up (NCT05134116) | Clinical Trial Compass
CompletedNot Applicable
SafeBoosC III Two-year Follow-up
Denmark1,601 participantsStarted 2021-09-23
Plain-language summary
The SafeBoosC-III 2 year follow up study will follow up on all patients randomised in the SafeBoosC-III clinical trial (NCT03770741). The investigators will collect data when the patients are two years of corrected age from routine standardised follow up assessments, parental questionnaires as well as informal assessments. The study will commence in September 2021, and will expect to include all 72 sites across 18 countries, which take part of the SafeBoosC-III clinical trial.
Who can participate
Age range
12 Months – 30 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:
Participation in the SafeBoosC-III trial and enrollment in a neonatal intensive care unit (NICU) taking part in the follow-up study, with parental consent according to local regulations.
Exclusion Criteria:
Parental objection to the use of their child's data in the follow-up study.
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
1
Death or moderate-or-severe neurodevelopmental disability
Timeframe: To be assessed at two years of corrected age
2
Mean Bayley III/IV cognitive score
Timeframe: To be assessed at two years of corrected age