HypoxiaPhase 3SafeBoosC-IIIvNCT05907317
Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)
A Phase 3 study testing Cerebral oximetry monitoring device in people with Hypoxia and Infant, Newborn, Diseases, run by Copenhagen Trial Unit, Center for Clinical Intervention Research at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Hypoxia, Infant, Newborn, Diseases
- What is being tested?
- Cerebral oximetry monitoring device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,610 participants
- Where
- 1 siteSpain
- Study dates
- 11 Apr 2025to 1 Feb 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age more than or equal to 28+0
- Postnatal age less than 28 days
- Expected to receive invasive mechanical ventilation (intubation) for at least 24 hours, as judged by the physician intending to randomise
- Parental informed consent unless the centre has chosen to use 'opt-out' or deferred consent as consent method
- A cerebral oximeter available so monitoring can be started within six hours after initiation of invasive mechanical ventilation
Who cannot join
- Suspicion of or confirmed brain injury or disorder (e.g. severe hypoxic-ischemic encephalopathy, intraventricular haemorrhage grade 3 or 4, cerebral malformation, genetic or metabolic disease)
- Suspicion or diagnosis of congenital heart malformations likely to require surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario 12 de Octubre
Madrid
Doctor, piris.salvador@gmail.com
About this study
Official title: Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv): Cerebral Oximetry Versus Usual Care in Mechanically Ventilated Newborns
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:
- 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.
Read the detailed description
SafeBoosC-IIIv will be an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. The trial will be conducted in two steps. In step one, 1,610 newborns will be randomised, and the outcomes will be assessed 90 days after randomisation. Funding has been obtained for step one. If further funding is obtained, we will continue to include newborns until a total of 3,000 newborns are randomised and then follow them up at two years of corrected age (step two).
- Conditions
- Hypoxia, Infant, Newborn, Diseases
- Being tested
- Cerebral oximetry monitoring device, Usual care
- Keywords
- Near-infrared spectroscopy, Randomised clinical trial, Mechanical ventilation
- Medical subject headings
- Hypoxia, Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral oximetry monitoring deviceDevice
Participants in the experimental group will be monitored with cerebral oximetry, if possible before or, as soon as possible and within six hours after initiation of invasive mechanical ventilation. Cerebral oximetry will be continued until 1) the cardio-pulmonary function has been stabilised as indicated by the need for respiratory and circulatory support and evaluated by the responsible physician, 2) extubation, 3) until 28 days after birth, or 4) until death. Randomisation will only direct the use of cerebral oximetry during the first invasive mechanical ventilation episode. Cerebral oximetry will be used to minimise cerebral hypoxia by modifying clinical care according to the SafeBoosC treatment guideline and monitoring as usual.
Usual careOther
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Cerebral oximetry + usual care | Experimental | Not described Receives: Device: Cerebral oximetry monitoring device; Other: Usual care |
| Usual care | Other | The control group will receive mechanical ventilation without access to cerebral oximetry and the SafeBoosC treatment guideline. If the newborn is cared for outside the neonatal unit at any time, e.g. during surgery, cerebral oximetry may or may not be used, as decided by the responsible physician there Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital-free days within 90 days of randomisation
Primary outcome for step one
Measured: 90 days
A composite of death from any cause or moderate to severe neurodevelopmental disability
Co-primary outcome for step two
A composite of death from any cause or moderate to severe neurodevelopmental disability at two years of corrected age. Moderate to severe neurodevelopmental disability will be defined as one or more of the following
- cerebral palsy with Global Motor Function Classification System level 2 or higher;
- a Parent Report of Children's Abilities-Revised (PARCA-R) non-verbal cognitive function score (range 0-34, higher score means better outcome) below -2 standard deviations (SD);
- hearing loss corrected with aids or worse; or
- vision impairment defined as moderately reduced vision of one eye, or only being able to perceive light or light reflecting objects; or blind in one eye with good vision in the contralateral eye.
Measured: 2 years
Parental questionnaires
Co-primary outcome for step two: Parental questionnaires completed between 18-30 months' corrected age as well as available data from at least 12 months' corrected age from health care records, including standardised neurodevelopmental assessments, will be used to assess mortality and neurodevelopment.
- Non-verbal cognitive score of Parent Report of Children's Abilities-Revised (PARCA-R), a parental questionnaire, at two years of corrected age (range 0-34, higher score means better outcome).
Measured: 18-30 months
Secondary outcomes (2)
Proportion of participants with a serious adverse event
Secondary outcome for step one: Proportion of participants with one or more Serious Adverse Events within the 90 days of randomization, i.e. one or more of the following:
Death from any cause Bronchopulmonary dysplasia (BPD) Any brain injury diagnosed by imaging Seizures treated with antiepileptic medicine Haemodynamic insufficiency that needs cardiovascular support Spontaneous bowel perforation or necrotising enterocolitis (NEC) Bells grade 2 or more Nosocomial infection Extra Corporal Membrane Oxygenation (ECMO) Renal replacement therapy
Measured: 90 days
Invasive mechanical ventilation-free days within 90 days of randomisation
Secondary outcome for step one
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start11 Apr 2025
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial will recruit 1610 babies in step one. Randomisation will continue until 3000 babies are recruited in step two.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen Trial Unit, Center for Clinical Intervention Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907317
- Sponsor's protocol ID
- SafeBoosC-IIIv
- Acronym
- SafeBoosC-IIIv
- Status last verified
- Jan 2025
- First submitted
- 8 Jun 2023
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vestager ML, Hansen ML, Rasmussen MI, Hahn GH, Hyttel-Sorensen S, Pellicer A, Heuchan AM, Hagmann C, Dempsey E, Dimitriou G, Pichler G, Naulaers G, Fuchs H, Tkaczyk J, Mintzer J, Fumagalli M, Nesargi S, Fredly S, Szczapa T, Gluud C, Jakobsen JC, Greisen G. The effects of cerebral oximetry in mechanically ventilated newborns: a protocol for the SafeBoosC-IIIv randomised clinical trial. Trials. 2023 Oct 28;24(1):696. doi: 10.1186/s13063-023-07699-x.
PubMed 37898759Kamp CB, Petersen JJ, Hansen ML, Pellicer A, Naulaers G, Dempsey E, Hahn GH, Olsen MH, Rasmussen MIS, Pichler G, Dimitriou G, Szczapa T, Ognean ML, Nesargi S, Musante G, Chalak L, Di Maio M, Lakhwani J, Procianoy RS, Tkaczyk J, Fuchs H, Cetinkaya M, Hagmann C, Popat H, Fabres J, Wang L, Schmolzer G, Fumagalli M, Piris-Borregas S, Mohora R, Zafra P, Sarafidis K, Alsina-Casanova M, Baik-Schneditz N, Lopez LS, Griesmaier E, Hatzidaki E, A S, Dassios T, Greisen G, Jakobsen JC. Treatment guided by cerebral oximetry in newborns receiving invasive mechanical ventilation: study protocol for step one of the SafeBoosC-IIIv randomised clinical trial. Trials. 2026 Mar 17;27(1):318. doi: 10.1186/s13063-026-09631-5.
PubMed 41845443Petersen JJ, Kamp CB, Olsen MH, Hansen ML, Thorlund K, Pellicer A, Naulaers G, Dempsey E, Hahn GH, Andersen PB, Rasmussen MIS, Pichler G, Dimitriou G, Szczapa T, Ognean ML, Nesargi S, Musante G, Chalak L, Di Maio M, Lakhwani J, Procianoy RS, Tkaczyk J, Fuchs H, Cetinkaya M, Hagmann C, Popat H, Fabres J, Wang L, Schmolzer G, Piris-Borregas S, Mohora R, Zafra P, Sarafidis K, Alsina-Casanova M, Baik-Schneditz N, Lopez LS, Griesmaier E, Hatzidaki E, Shashidhar A, Dassios T, Arruza L, Greisen G, Jakobsen JC. Treatment guided by cerebral oximetry in mechanically ventilated newborns: a statistical analysis plan for step one of the SafeBoosC-IIIv randomised clinical trial. Trials. 2025 Dec 18;27(1):72. doi: 10.1186/s13063-025-09387-4.
PubMed 41413912
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv): Cerebral Oximetry Versus Usual Care in Mechanically Ventilated Newborns
- ClinicalTrials.gov ID
- NCT05907317
- Acronym / sponsor ID
- SafeBoosC-IIIv / SafeBoosC-IIIv
- Conditions
- Hypoxia, Infant, Newborn, Diseases
- Keywords
- Near-infrared spectroscopy, Randomised clinical trial, Mechanical ventilation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,610 participants (estimated)
- Lead sponsor
- Copenhagen Trial Unit, Center for Clinical Intervention ResearchUniversity, hospital or other
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Detailed description
SafeBoosC-IIIv will be an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. The trial will be conducted in two steps. In step one, 1,610 newborns will be randomised, and the outcomes will be assessed 90 days after randomisation. Funding has been obtained for step one. If further funding is obtained, we will continue to include newborns until a total of 3,000 newborns are randomised and then follow them up at two years of corrected age (step two).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The trial will recruit 1610 babies in step one. Randomisation will continue until 3000 babies are recruited in step two.
| Arm | Type | Receives |
|---|---|---|
| Cerebral oximetry + usual care | Experimental | Device: Cerebral oximetry monitoring device, Other: Usual care |
| Usual care | Other | Other: Usual careThe control group will receive mechanical ventilation without access to cerebral oximetry and the SafeBoosC treatment guideline. If the newborn is cared for outside the neonatal unit at any time, e.g. during surgery, cerebral oximetry may or may not be used, as decided by the responsible physician there |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Gestational age more than or equal to 28+0
- Postnatal age less than 28 days
- Expected to receive invasive mechanical ventilation (intubation) for at least 24 hours, as judged by the physician intending to randomise
- Parental informed consent unless the centre has chosen to use 'opt-out' or deferred consent as consent method
- A cerebral oximeter available so monitoring can be started within six hours after initiation of invasive mechanical ventilation
Key exclusion criteria (2 listed)
- Suspicion of or confirmed brain injury or disorder (e.g. severe hypoxic-ischemic encephalopathy, intraventricular haemorrhage grade 3 or 4, cerebral malformation, genetic or metabolic disease)
- Suspicion or diagnosis of congenital heart malformations likely to require surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral oximetry monitoring deviceParticipants in the experimental group will be monitored with cerebral oximetry, if possible before or, as soon as possible and within six hours after initiation of invasive mechanical ventilation. Cerebral oximetry will be continued until 1) the cardio-pulmonary function has been stabilised as indicated by the need for respiratory and circulatory support and evaluated by the responsible physician, 2) extubation, 3) until 28 days after birth, or 4) until death. Randomisation will only direct the use of cerebral oximetry during the first invasive mechanical ventilation episode. Cerebral oximetry will be used to minimise cerebral hypoxia by modifying clinical care according to the SafeBoosC treatment guideline and monitoring as usual. | Device | Cerebral oximetry + usual care |
| Usual careTreatment as usual | Other | Cerebral oximetry + usual care, Usual care |
Primary outcome
Hospital-free days within 90 days of randomisation
Time frame: 90 days
Primary outcome for step one
A composite of death from any cause or moderate to severe neurodevelopmental disability
Time frame: 2 years
Co-primary outcome for step two A composite of death from any cause or moderate to severe neurodevelopmental disability at two years of corrected age. Moderate to severe neurodevelopmental disability will be defined as one or more of the following 1. cerebral palsy with Global Motor Function Classification System level 2 or higher; 2. a Parent Report of Children's Abilities-Revised (PARCA-R) non-verbal cognitive function score (range 0-34, higher score means better outcome) below -2 standard deviations (SD); 3. hearing loss corrected with aids or worse; or 4. vision impairment defined as moderately reduced vision of one eye, or only being able to perceive light or light reflecting objects; or blind in one eye with good vision in the contralateral eye.
Parental questionnaires
Time frame: 18-30 months
Co-primary outcome for step two: Parental questionnaires completed between 18-30 months' corrected age as well as available data from at least 12 months' corrected age from health care records, including standardised neurodevelopmental assessments, will be used to assess mortality and neurodevelopment. • Non-verbal cognitive score of Parent Report of Children's Abilities-Revised (PARCA-R), a parental questionnaire, at two years of corrected age (range 0-34, higher score means better outcome).
2 secondary outcomes
Proportion of participants with a serious adverse event
Time frame: 90 days
Invasive mechanical ventilation-free days within 90 days of randomisation
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Background: PubMed 37898759Vestager ML, Hansen ML, Rasmussen MI, Hahn GH, Hyttel-Sorensen S, Pellicer A, Heuchan AM, Hagmann C, Dempsey E, Dimitriou G, Pichler G, Naulaers G, Fuchs H, Tkaczyk J, Mintzer J, Fumagalli M, Nesargi S, Fredly S, Szczapa T, Gluud C, Jakobsen JC, Greisen G. The effects of cerebral oximetry in mechanically ventilated newborns: a protocol for the SafeBoosC-IIIv randomised clinical trial. Trials. 2023 Oct 28;24(1):696. doi: 10.1186/s13063-023-07699-x.
- Derived from this study: PubMed 41845443Kamp CB, Petersen JJ, Hansen ML, Pellicer A, Naulaers G, Dempsey E, Hahn GH, Olsen MH, Rasmussen MIS, Pichler G, Dimitriou G, Szczapa T, Ognean ML, Nesargi S, Musante G, Chalak L, Di Maio M, Lakhwani J, Procianoy RS, Tkaczyk J, Fuchs H, Cetinkaya M, Hagmann C, Popat H, Fabres J, Wang L, Schmolzer G, Fumagalli M, Piris-Borregas S, Mohora R, Zafra P, Sarafidis K, Alsina-Casanova M, Baik-Schneditz N, Lopez LS, Griesmaier E, Hatzidaki E, A S, Dassios T, Greisen G, Jakobsen JC. Treatment guided by cerebral oximetry in newborns receiving invasive mechanical ventilation: study protocol for step one of the SafeBoosC-IIIv randomised clinical trial. Trials. 2026 Mar 17;27(1):318. doi: 10.1186/s13063-026-09631-5.
- Derived from this study: PubMed 41413912Petersen JJ, Kamp CB, Olsen MH, Hansen ML, Thorlund K, Pellicer A, Naulaers G, Dempsey E, Hahn GH, Andersen PB, Rasmussen MIS, Pichler G, Dimitriou G, Szczapa T, Ognean ML, Nesargi S, Musante G, Chalak L, Di Maio M, Lakhwani J, Procianoy RS, Tkaczyk J, Fuchs H, Cetinkaya M, Hagmann C, Popat H, Fabres J, Wang L, Schmolzer G, Piris-Borregas S, Mohora R, Zafra P, Sarafidis K, Alsina-Casanova M, Baik-Schneditz N, Lopez LS, Griesmaier E, Hatzidaki E, Shashidhar A, Dassios T, Arruza L, Greisen G, Jakobsen JC. Treatment guided by cerebral oximetry in mechanically ventilated newborns: a statistical analysis plan for step one of the SafeBoosC-IIIv randomised clinical trial. Trials. 2025 Dec 18;27(1):72. doi: 10.1186/s13063-025-09387-4.
- Official website of the trialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Hypoxia
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Enrolling by invitation
Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring
Hypoxemia
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Active, not recruitingPhase 3
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Carcinoma, Renal Cell
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cerebral oximetry monitoring device in people with Hypoxia and Infant, Newborn, Diseases, run by Copenhagen Trial Unit, Center for Clinical Intervention Research at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Kamp, PhD (+45 20 32 41 08, caroline.kamp@ctu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital-free days within 90 days of randomisation (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05907317, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.