Last reviewed · How we verify
NCT05134116
SafeBoosC III Two-year Follow-up
trial testing Treatment as usual + cerebral oximetry monitoring the first 72 hours of life in Deficits, Neurologic in 1,601 participants. Completed in 19 October 2024.
19 October 2024
Quick facts
| Lead sponsor | Gorm Greisen |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,601 |
| Start date | 23 September 2021 |
| Primary completion | 19 October 2024 |
| Estimated completion | 19 October 2024 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Treatment as usual + cerebral oximetry monitoring the first 72 hours of life
Conditions studied
- Deficits, Neurologic — all drugs for Deficits, Neurologic →
- Extreme Prematurity — all drugs for Extreme Prematurity →
- Brain Damage — all drugs for Brain Damage →
Sponsor
Gorm Greisen
Who can join
Adults 12 Months to 30 Months, any sex, with Deficits, Neurologic or Extreme Prematurity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cerebral oximetry monitoring versus usual care for extremely preterm infants: a study protocol for the 2-year follow-up of the SafeBoosC-III randomised clinical trial.
Rasmussen MI, Hansen ML, Pellicer A, Gluud C, et al · · 2023 · cited 7× · PMID 37805539 · DOI 10.1186/s13063-023-07653-x -
Cerebral oximetry monitoring versus usual care for extremely preterm infants: a detailed statistical analysis plan for the 2-year follow-up of the participants of the SafeBoosC-III randomised clinical trial.
Rasmussen MIS, Hansen ML, Pellicer A, Gluud C, et al · · 2026 · cited 1× · PMID 41491571 · DOI 10.1186/s13063-025-09392-7 -
Cerebral Oximetry in Extremely Preterm Infants: 2-Year Follow-Up of the SafeBoosC-III Randomized Clinical Trial.
Rasmussen MIS, Hansen ML, Pellicer A, Hyttel-Sørensen S, et al · · 2026 · PMID 42008246 · DOI 10.1001/jamapediatrics.2026.1066 -
Cerebral oximetry monitoring versus usual care for extremely preterm infants: a study protocol for the two-year follow up of the SafeBoosC-III randomised clinical trial
Rasmussen MIS, Hansen ML, Pellicer A, Gluud C, et al · · 2023 · DOI 10.21203/rs.3.rs-2845005/v1
Verify or expand the search:
- PubMed search for NCT05134116
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Gorm Greisen trials
Trials by the same sponsor.
- NCT03983694 — Cerebral Haemodynamic Changes by Red Blood Cell Transfusion in Neonates · completed
- NCT03770741 — Safeguarding the Brain of Our Smallest Infants Phase III · NA · completed
- NCT03091907 — Long-term Consequences of Necrotizing Enterocolitis in the Newborn Period · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05134116 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gorm Greisen
- Last refreshed: 7 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05134116.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing