NCT03770741: SafeBoosC

Safeguarding the Brain of Our Smallest Infants Phase III

Completed NA Last updated 20 December 2021

What this trial tests

NA trial testing Modify cardio-respiratory support to avoid cerebral hypoxia in Infant, Extremely Premature in 1,601 participants. Completed in 16 December 2021.

Timeline

20 June 2019

Primary endpoint
16 December 2021

16 December 2021

Quick facts

Lead sponsor	Gorm Greisen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,601
Start date	20 June 2019
Primary completion	16 December 2021
Estimated completion	16 December 2021
Sites	1 location across Denmark

Drugs / interventions tested

• Modify cardio-respiratory support to avoid cerebral hypoxia
• Treatment as usual

Conditions studied

• Infant, Extremely Premature — all drugs for Infant, Extremely Premature →
• Brain Injuries — all drugs for Brain Injuries →
• Death, Brain — all drugs for Death, Brain →
• Death; Neonatal — all drugs for Death; Neonatal →

Sponsor

Gorm Greisen

Who can join

Under 6 Hours, any sex, with Infant, Extremely Premature or Brain Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

the SafeBoosC-III trial investigates the benefit and harms of treatment based on near-infrared spectroscopy monitoring compared with treatment as usual. The hypothesis is that treatment based on near-infrared spectroscopy monitoring for extremely preterm infants during the first 72 hours of life will result in a reduction in severe brain injury or death at 36 weeks postmenstrual age.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cerebral Oximetry Monitoring in Extremely Preterm Infants.
   Hansen ML, Pellicer A, Hyttel-Sørensen S, Ergenekon E, et al · · 2023 · cited 77× · PMID 37075142 · DOI 10.1056/nejmoa2207554
2. Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial.
   Hansen ML, Pellicer A, Gluud C, Dempsey E, et al · · 2019 · cited 48× · PMID 31888764 · DOI 10.1186/s13063-019-3955-6
3. Cerebral Oximetry in Preterm Infants-To Use or Not to Use, That Is the Question.
   Greisen G, Hansen ML, Rasmussen MIS, Vestager M, et al · · 2021 · cited 9× · PMID 35186815 · DOI 10.3389/fped.2021.747660
4. Detailed statistical analysis plan for the SafeBoosC III trial: a multinational randomised clinical trial assessing treatment guided by cerebral oxygenation monitoring versus treatment as usual in extremely preterm infants.
   Hansen ML, Pellicer A, Gluud C, Dempsey E, et al · · 2019 · cited 9× · PMID 31856902 · DOI 10.1186/s13063-019-3756-y
5. 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
6. Pilot test of an online training module on near-infrared spectroscopy monitoring for the randomised clinical trial SafeBoosC-III.
   Hansen ML, Rasmussen MI, Rubin S, Pellicer A, et al · · 2020 · cited 4× · PMID 32326953 · DOI 10.1186/s13063-020-4206-6
7. Web-based training and certification of clinical staff during the randomised clinical trial SafeBoosC-III.
   Rasmussen MIS, Hansen ML, Peters C, Greisen G, et al · · 2024 · cited 1× · PMID 39444031 · DOI 10.1186/s13063-024-08530-x
8. Treatment guided by cerebral oximetry monitoring in extremely preterm infants: a Bayesian analysis of the SafeBoosC-III randomised clinical trial.
   Hansen ML, Olsen MH, Lange T, Gluud C, et al · · 2026 · PMID 42050627 · DOI 10.1186/s13063-026-09742-z