Cerebral Near-infrared Spectroscopy Monitoring Versus Treatment as Usual for Extremely Preterm Infants: a Protocol for the Follow-up Study for the SafeBoosC-III Trial
Status: Completed
Location: See location...
Intervention Type: Other
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 2
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Denmark
Righospitalet (The University Hospital, Copenhagen)
Copenhagen
Time Frame
Start Date: 2021-09-23
Completion Date: 2024-10-19
Participants
Target number of participants: 1601
Related Therapeutic Areas
Sponsors
Leads: Gorm Greisen