NCT05907317 (SafeBoosC-IIIv) is a Phase 3 clinical trial of Cerebral oximetry monitoring device in Hypoxia, sponsored by Copenhagen Trial Unit, Center for Clinical Intervention Research.

Who is sponsoring NCT05907317?

NCT05907317 is sponsored by Copenhagen Trial Unit, Center for Clinical Intervention Research.

What drugs are being tested in NCT05907317?

Interventions in NCT05907317: Cerebral oximetry monitoring device, Usual care.

What condition does NCT05907317 study?

NCT05907317 studies Hypoxia, Infant, Newborn, Diseases.

Is NCT05907317 still recruiting?

NCT05907317 is currently recruiting now. Last updated 25 April 2025.

Last reviewed 2025-04-25 · How we verify

NCT05907317: SafeBoosC-IIIv

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)

Recruiting now Phase 3 Last updated 25 April 2025

What this trial tests

Phase 3 trial testing Cerebral oximetry monitoring device in Hypoxia in 1,610 participants. Currently enrolling.

Timeline

11 April 2025

Primary endpoint
1 February 2029

1 February 2029

Quick facts

Lead sponsor	Copenhagen Trial Unit, Center for Clinical Intervention Research
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,610
Start date	11 April 2025
Primary completion	1 February 2029
Estimated completion	1 February 2029
Sites	1 location across Spain

Drugs / interventions tested

Cerebral oximetry monitoring device
Usual care

Conditions studied

Hypoxia — all drugs for Hypoxia →
Infant, Newborn, Diseases — all drugs for Infant, Newborn, Diseases →

Sponsor

Copenhagen Trial Unit, Center for Clinical Intervention Research

Who can join

Adults 0 Days to 28 Days, any sex, with Hypoxia or Infant, Newborn, Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of the SafeBoosC-IIIv trial is to assess benefits and harms of cerebral oximetry in newborns receiving invasive mechanical ventilation. The hypothesis is that: i. Cerebral oximetry added to usual care versus usual care alone in newborns receiving invasive mechanical ventilation will increase the number of hospital-free days within 90 days of randomisation. ii. The intervention will decrease a composite outcome of death or moderate to severe neurodevelopmental disability and/or increase the mean PARCA-R non-verbal cognitive score at two years of corrected age.

Publications & conference data

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

Treatment guided by cerebral oximetry in mechanically ventilated newborns: a statistical analysis plan for step one of the SafeBoosC-IIIv randomised clinical trial.
Petersen JJ, Kamp CB, Olsen MH, Hansen ML, et al · · 2025 · cited 2× · PMID 41413912 · DOI 10.1186/s13063-025-09387-4
Treatment guided by cerebral oximetry in newborns receiving invasive mechanical ventilation: study protocol for step one of the SafeBoosC-IIIv randomised clinical trial.
Kamp CB, Petersen JJ, Hansen ML, Pellicer A, et al · · 2026 · PMID 41845443 · DOI 10.1186/s13063-026-09631-5
The effects of cerebral oximetry in mechanically ventilated newborns: a protocol for the SafeBoosC-IIIv randomised clinical trial.
Vestager ML, Hansen ML, Rasmussen MI, Hahn GH, et al · · 2023 · PMID 37898759 · DOI 10.1186/s13063-023-07699-x
The effects of cerebral oximetry in mechanically ventilated newborns: a protocol for the SafeBoosC-IIIv randomised clinical trial
Vestager ML, Hansen ML, Rasmussen MI, Hahn GH, et al · · 2023 · DOI 10.21203/rs.3.rs-3082889/v1

Verify or expand the search:

Other recruiting trials for Hypoxia

Currently open trials in the same condition.

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NCT07287293 — Endotracheal Tube Suctioning Versus No Suctioning During Emergence From General Anesthesia · NA · recruiting
NCT07389083 — The Efficacy and Safety of the Supraglottic Oxygenation Via Nasotracheal Intubation for Deep Sedation Fiberoptic Broncho · NA · recruiting
NCT07307560 — High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients · NA · recruiting
NCT07408388 — Pulse Oximeter Accuracy During Stable Hypoxia Plateaus · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05907317 (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 Copenhagen Trial Unit, Center for Clinical Intervention Research
Last refreshed: 25 April 2025

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/NCT05907317.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing