Infant, Extremely PrematureSafeBoosCNCT03770741
Safeguarding the Brain of Our Smallest Infants Phase III
A study testing Modify cardio-respiratory support to avoid cerebral hypoxia and Treatment as usual in people with Infant, Extremely Premature and Brain Injuries, run by Gorm Greisen at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 6 hours
- Conditions the study is for
- Infant, Extremely Premature, Brain Injuries, Death, Brain
- What is being tested?
- Modify cardio-respiratory support to avoid cerebral hypoxia and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,601 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Jun 2019to 16 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born with postmenstrual age less than 28 weeks
- Signed informed consent, unless the NICU has chosen to use 'opt-out' or deferred consent as consent method.
Who cannot join
- Missing written parental informed consent (if the 'opt-out' method is used for consent, lack of a record that the clinical staff have explained the trial and the 'opt-out' consent process to parents and/or a record in the infant's clinical file of parents' decision to opt-out, are exclusion criteria)
- Decision not to conduct full life support
- No possibility to place cerebral NIRS oximeter within six hours after birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safeguarding the Brain of Our Smallest Children - an Investigator-initiated, Pragmatic, Open Label, Multinational Randomized Phase IIIclinical Trial Evaluating Treatment Based on Near-infrared Spectroscopy Monitoring Versus Treatment as Usual in Premature Infants
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.
Read the detailed description
Background Each year, 50,000 extremely preterm infants are born in high-income countries with access to neonatal intensive care. Of these, 10,000 will die and a further 10,000 will suffer cerebral palsy or moderate-to-severe neuro-cognitive disability. Time spent outside normal cerebral oxygenation ranges (time with hypoxia or hyperoxia) is associated with poor neurological outcome in children and adults. Monitoring of cerebral oxygenation may reduce the risk of cerebral complications, but no such effects have yet been demonstrated in preterm infants in large randomised clinical trials. The recently completed SafeBoosC phase II trial was conducted at eight sites in eight European countries. 166 extremely preterm infants were randomised to visible monitoring of cerebral oxygenation by near-infrared spectroscopy (NIRS) combined with an evidence-based treatment guideline (experimental group) versus blinded NIRS and treatment as usual (control group). The trial found that NIRS monitoring in combination with an evidence-based treatment guideline successfully reduced the burden of hypoxia and hyperoxia from 81% to 36%hours during the first three days of life (p<0.001). Furthermore, the proportion of severe brain injury assessed by central reading of serial cranial ultrasound was 12.5% in the experimental group versus 23.4% in the control group, RR 0.53 (95% CI: 0.26 to 1.08). Mortality was 14% in the experimental versus 25% in the control group, RR 0.50 (95% CI: 0.29 to 1.00). No other evidence has been identified. Based on these preliminary findings, we are planning a phase III randomised clinical trial; the SafeBoosC-III trial.
Objectives The overall objective of the SafeBoosC-III trial is to investigate 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.
Trial design The SafeBoosC-III trial will be an investigator-initiated, randomized, multinational, pragmatic phase-III clinically open trial with a two-parallel group design. Sixteen-hundred extremely preterm infants will be included within 24 months at 50 neonatal intensive care units (NICUs) across 20 countries (less than two children per month per unit). Data management and statistical analysis will be blinded.
Eligibility Eligible infants will be born before 28 weeks of postmenstrual age; decision is made to provide full life support; signed informed consent (unless the NICU has chosen to use 'opt-out' or deferred consent as consent method); and cerebral NIRS oximeter placed within 6 hours after birth.
Interventions Participants in the experimental group will be monitored during the first 72 hours of life with a cerebral NIRS oximeter, placed within six hours after birth, and treated according to an evidence-based treatment guideline. Participants in the control group will not undergo cerebral oxygenation monitoring and will be treated as usual. Each participant will be followed up at 36 weeks postmenstrual age.
Outcomes The primary outcome will be a composite of severe brain injury (cerebral haemorrhage grade III or IV, cystic periventricular leukomalacia, cerebellar haemorrhage, post-haemorrhagic ventricular dilatation or cerebral atrophy) detected on any of the serial cranial ultrasound scans that are routinely performed in these infants up to that age or death until 36 weeks of postmenstrual age.
Exploratory outcomes will be a count of the presence of bronchopulmonary dysplasia, retinopathy of prematurity stage 3+, and severe brain injury as defined in the primary outcome, as well as bronchopulmonary dysplasia, retinopathy of prematurity stage +3, necrotizing enterocolitis stage 2 or higher using the modified Bell's staging and/or focal intestinal perforation, and late-onset sepsis (>72 hours after birth) defined as treatment with antibiotics for at least five days, as isolated outcomes.
Sample size We have calculated our sample size based on the primary outcome with an alpha of 5%, a power of 90%, and a ratio of 1:1 between intervention groups. In the SafeBoosC-II trial, the proportion of trial participants in the control group with death or severe brain injury was approximately 34%. Assuming the same proportion in the SafeBoosC phase III trial control group and using 22% relative risk reduction as anticipated intervention effect, we will need to randomise a total of 1,600 participants.
Safety Oximeters approved for clinical use in newborn infants will be used. Predefined serious adverse events and serious adverse reactions will be reported separately. An independent Data Monitoring and Safety Committee will be established to monitor the safety of the trial participants during the trial.
Ethical considerations Approval from the relevant ethics committees and/or Institutional Review Boards is mandatory for every participating centre. Written parental informed consent will be obtained prior to randomisation unless the ethics committee has granted permission to use deferred informed consent or prior informed assent. The trial will be conducted in compliance with the guidelines of the Declaration of Helsinki in its latest form and of the International Conference on Harmonisation Good Clinical Practice. Procedures will be established to prevent and minimise risk of complications for participants, such as complications related to the device handling. The evidence-based treatment guideline includes only interventions that are commonly used during intensive care for this population.
Trial duration Recruitment will begin in April of 2019 and will be completed within 24 months (April of 2021).
Perspectives If the experimental intervention proves successful, we may save at least 2,000 extremely preterm infants every year from death or a life with a handicap due to brain injury in high-income countries. The ensuing health economics impact running into billions of Euros saved annually.
- Being tested
- Modify cardio-respiratory support to avoid cerebral hypoxia, Treatment as usual
- Keywords
- Near-infrared spectroscopy, NIRS, Cerebral oximetry, Extremely preterm, Brain injury, Mortality, Treatment guideline
- Medical subject headings
- Brain Injuries, Brain Death, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modify cardio-respiratory support to avoid cerebral hypoxiaOther
modification of cardio-respiratory support based on an evidence-based treatment guideline
Treatment as usualOther
Monitoring and treatment according to local guidelines and practice
| Study group | Role | What they receive |
|---|---|---|
| Monitoring of cerebral oxygenation | Experimental | Modify cardio-respiratory support to avoid cerebral hypoxia Receives: Other: Modify cardio-respiratory support to avoid cerebral hypoxia |
| Treatment as usual | Other | Treatment according local guidelines and practices. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe brain injury or death
A composite of severe brain injury detected on any one of a series of cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age or death at 36 weeks postmenstrual age
Measured: From birth to 36 weeks postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start20 Jun 2019
- Primary completion16 Dec 2021
- Study completion16 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Infant, Extremely PrematureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gorm Greisen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research, Elsass Foundation
- Responsible party
- Sponsor-investigator, Gorm Greisen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Gorm Greisen, MD, Prof, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770741
- Sponsor's protocol ID
- SafeBoosC-DP-363
- Acronym
- SafeBoosC
- Status last verified
- Dec 2021
- First submitted
- 7 Dec 2018
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hyttel-Sorensen S, Pellicer A, Alderliesten T, Austin T, van Bel F, Benders M, Claris O, Dempsey E, Franz AR, Fumagalli M, Gluud C, Grevstad B, Hagmann C, Lemmers P, van Oeveren W, Pichler G, Plomgaard AM, Riera J, Sanchez L, Winkel P, Wolf M, Greisen G. Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial. BMJ. 2015 Jan 5;350:g7635. doi: 10.1136/bmj.g7635.
PubMed 25569128Hansen ML, Olsen MH, Lange T, Gluud C, Haugegaard T, Christensen R, Thabane L, Greisen G, Jakobsen JC; SafeBoosC-III Trial Group. Treatment guided by cerebral oximetry monitoring in extremely preterm infants: a Bayesian analysis of the SafeBoosC-III randomised clinical trial. Trials. 2026 Apr 29;27(1):441. doi: 10.1186/s13063-026-09742-z.
PubMed 42050627Rasmussen MIS, Hansen ML, Peters C, Greisen G; SafeBoosC-III Trial Group. Web-based training and certification of clinical staff during the randomised clinical trial SafeBoosC-III. Trials. 2024 Oct 23;25(1):711. doi: 10.1186/s13063-024-08530-x.
PubMed 39444031Olsen MH, Hansen ML, Lange T, Gluud C, Thabane L, Greisen G, Jakobsen JC; SafeBoosC-III Trial Group. Detailed statistical analysis plan for a secondary Bayesian analysis of the SafeBoosC-III trial: a multinational, randomised clinical trial assessing treatment guided by cerebral oximetry monitoring versus usual care in extremely preterm infants. Trials. 2023 Nov 16;24(1):737. doi: 10.1186/s13063-023-07720-3.
PubMed 37974280Hansen ML, Pellicer A, Hyttel-Sorensen S, Ergenekon E, Szczapa T, Hagmann C, Naulaers G, Mintzer J, Fumagalli M, Dimitriou G, Dempsey E, Tkaczyk J, Cheng G, Fredly S, Heuchan AM, Pichler G, Fuchs H, Nesargi S, Hahn GH, Piris-Borregas S, Sirc J, Alsina-Casanova M, Stocker M, Ozkan H, Sarafidis K, Hopper AO, Karen T, Rzepecka-Weglarz B, Oguz SS, Arruza L, Memisoglu AC, Del Rio Florentino R, Baserga M, Maton P, Truttmann AC, de Las Cuevas I, Agergaard P, Zafra P, Bender L, Lauterbach R, Lecart C, de Buyst J, El-Khuffash A, Curley A, Vaccarello OO, Miletin J, Papathoma E, Vesoulis Z, Vento G, Cornette L, Lopez LS, Yasa B, Klamer A, Agosti M, Baud O, Mastretta E, Cetinkaya M, McCall K, Zeng S, Hatzidaki E, Bargiel A, Marciniak S, Gao X, Huijia L, Chalak L, Yang L, Rao SA, Xu X, Gonzalez BL, Wilinska M, Yin Z, Sadowska-Krawczenko I, Serrano-Vinuales I, Krolak-Olejnik B, Ybarra MM, Morales-Betancourt C, Korcek P, Teresa-Palacio M, Mosca F, Hergenhan A, Koksal N, Tsoni K, Kadri MM, Knopfli C, Rafinska-Wazny E, Akin MS, Nordvik T, Peng Z, Kersin SG, Thewissen L, Alarcon A, Healy D, Urlesberger B, Bas M, Baumgartner J, Skylogianni E, Karadyova V, Valverde E, Bergon-Sendin E, Kucera J, Pisoni S, Wang L, Smits A, Sanchez-Salmador R, Rasmussen MI, Olsen MH, Jensen AK, Gluud C, Jakobsen JC, Greisen G. Cerebral Oximetry Monitoring in Extremely Preterm Infants. N Engl J Med. 2023 Apr 20;388(16):1501-1511. doi: 10.1056/NEJMoa2207554.
PubMed 37075142Hansen ML, Rasmussen MI, Rubin S, Pellicer A, Cheng G, Xu X, Zhaoqing Y, Zoffmann V, Greisen G. Pilot test of an online training module on near-infrared spectroscopy monitoring for the randomised clinical trial SafeBoosC-III. Trials. 2020 Apr 23;21(1):356. doi: 10.1186/s13063-020-4206-6.
PubMed 32326953Hansen ML, Pellicer A, Gluud C, Dempsey E, Mintzer J, Hyttel-Sorensen S, Heuchan AM, Hagmann C, Ergenekon E, Dimitriou G, Pichler G, Naulaers G, Cheng G, Guimaraes H, Tkaczyk J, Kreutzer KB, Fumagalli M, Claris O, Lemmers P, Fredly S, Szczapa T, Austin T, Jakobsen JC, Greisen G. Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial. Trials. 2019 Dec 30;20(1):811. doi: 10.1186/s13063-019-3955-6.
PubMed 31888764Hansen ML, Pellicer A, Gluud C, Dempsey E, Mintzer J, Hyttel-Sorensen S, Heuchan AM, Hagmann C, Dimitriou G, Pichler G, Naulaers G, Cheng G, Vilan A, Tkaczyk J, Kreutzer KB, Fumagalli M, Claris O, Fredly S, Szczapa T, Lange T, Jakobsen JC, Greisen G. 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. Trials. 2019 Dec 19;20(1):746. doi: 10.1186/s13063-019-3756-y.
PubMed 31856902
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safeguarding the Brain of Our Smallest Children - an Investigator-initiated, Pragmatic, Open Label, Multinational Randomized Phase IIIclinical Trial Evaluating Treatment Based on Near-infrared Spectroscopy Monitoring Versus Treatment as Usual in Premature Infants
- ClinicalTrials.gov ID
- NCT03770741
- Acronym / sponsor ID
- SafeBoosC / SafeBoosC-DP-363
- Keywords
- Near-infrared spectroscopy, NIRS, Cerebral oximetry, Extremely preterm, Brain injury, Mortality, Treatment guideline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,601 participants (actual)
- Lead sponsor
- Gorm GreisenUniversity, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research, Elsass Foundation
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 10 Dec 2018 (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 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.
Detailed description
Background Each year, 50,000 extremely preterm infants are born in high-income countries with access to neonatal intensive care. Of these, 10,000 will die and a further 10,000 will suffer cerebral palsy or moderate-to-severe neuro-cognitive disability. Time spent outside normal cerebral oxygenation ranges (time with hypoxia or hyperoxia) is associated with poor neurological outcome in children and adults. Monitoring of cerebral oxygenation may reduce the risk of cerebral complications, but no such effects have yet been demonstrated in preterm infants in large randomised clinical trials. The recently completed SafeBoosC phase II trial was conducted at eight sites in eight European countries. 166 extremely preterm infants were randomised to visible monitoring of cerebral oxygenation by near-infrared spectroscopy (NIRS) combined with an evidence-based treatment guideline (experimental group) versus blinded NIRS and treatment as usual (control group). The trial found that NIRS monitoring in combination with an evidence-based treatment guideline successfully reduced the burden of hypoxia and hyperoxia from 81% to 36%hours during the first three days of life (p<0.001). Furthermore, the proportion of severe brain injury assessed by central reading of serial cranial ultrasound was 12.5% in the experimental group versus 23.4% in the control group, RR 0.53 (95% CI: 0.26 to 1.08). Mortality was 14% in the experimental versus 25% in the control group, RR 0.50 (95% CI: 0.29 to 1.00). No other evidence has been identified. Based on these preliminary findings, we are planning a phase III randomised clinical trial; the SafeBoosC-III trial.
Objectives The overall objective of the SafeBoosC-III trial is to investigate 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.
Trial design The SafeBoosC-III trial will be an investigator-initiated, randomized, multinational, pragmatic phase-III clinically open trial with a two-parallel group design. Sixteen-hundred extremely preterm infants will be included within 24 months at 50 neonatal intensive care units (NICUs) across 20 countries (less than two children per month per unit). Data management and statistical analysis will be blinded.
Eligibility Eligible infants will be born before 28 weeks of postmenstrual age; decision is made to provide full life support; signed informed consent (unless the NICU has chosen to use 'opt-out' or deferred consent as consent method); and cerebral NIRS oximeter placed within 6 hours after birth.
Interventions Participants in the experimental group will be monitored during the first 72 hours of life with a cerebral NIRS oximeter, placed within six hours after birth, and treated according to an evidence-based treatment guideline. Participants in the control group will not undergo cerebral oxygenation monitoring and will be treated as usual. Each participant will be followed up at 36 weeks postmenstrual age.
Outcomes The primary outcome will be a composite of severe brain injury (cerebral haemorrhage grade III or IV, cystic periventricular leukomalacia, cerebellar haemorrhage, post-haemorrhagic ventricular dilatation or cerebral atrophy) detected on any of the serial cranial ultrasound scans that are routinely performed in these infants up to that age or death until 36 weeks of postmenstrual age.
Exploratory outcomes will be a count of the presence of bronchopulmonary dysplasia, retinopathy of prematurity stage 3+, and severe brain injury as defined in the primary outcome, as well as bronchopulmonary dysplasia, retinopathy of prematurity stage +3, necrotizing enterocolitis stage 2 or higher using the modified Bell's staging and/or focal intestinal perforation, and late-onset sepsis (>72 hours after birth) defined as treatment with antibiotics for at least five days, as isolated outcomes.
Sample size We have calculated our sample size based on the primary outcome with an alpha of 5%, a power of 90%, and a ratio of 1:1 between intervention groups. In the SafeBoosC-II trial, the proportion of trial participants in the control group with death or severe brain injury was approximately 34%. Assuming the same proportion in the SafeBoosC phase III trial control group and using 22% relative risk reduction as anticipated intervention effect, we will need to randomise a total of 1,600 participants.
Safety Oximeters approved for clinical use in newborn infants will be used. Predefined serious adverse events and serious adverse reactions will be reported separately. An independent Data Monitoring and Safety Committee will be established to monitor the safety of the trial participants during the trial.
Ethical considerations Approval from the relevant ethics committees and/or Institutional Review Boards is mandatory for every participating centre. Written parental informed consent will be obtained prior to randomisation unless the ethics committee has granted permission to use deferred informed consent or prior informed assent. The trial will be conducted in compliance with the guidelines of the Declaration of Helsinki in its latest form and of the International Conference on Harmonisation Good Clinical Practice. Procedures will be established to prevent and minimise risk of complications for participants, such as complications related to the device handling. The evidence-based treatment guideline includes only interventions that are commonly used during intensive care for this population.
Trial duration Recruitment will begin in April of 2019 and will be completed within 24 months (April of 2021).
Perspectives If the experimental intervention proves successful, we may save at least 2,000 extremely preterm infants every year from death or a life with a handicap due to brain injury in high-income countries. The ensuing health economics impact running into billions of Euros saved annually.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitoring of cerebral oxygenation | Experimental | Other: Modify cardio-respiratory support to avoid cerebral hypoxiaModify cardio-respiratory support to avoid cerebral hypoxia |
| Treatment as usual | Other | Other: Treatment as usualTreatment according local guidelines and practices. |
Who may qualify
- Ages
- Up to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants born with postmenstrual age less than 28 weeks
- Signed informed consent, unless the NICU has chosen to use 'opt-out' or deferred consent as consent method.
Key exclusion criteria (3 listed)
- Missing written parental informed consent (if the 'opt-out' method is used for consent, lack of a record that the clinical staff have explained the trial and the 'opt-out' consent process to parents and/or a record in the infant's clinical file of parents' decision to opt-out, are exclusion criteria)
- Decision not to conduct full life support
- No possibility to place cerebral NIRS oximeter within six hours after birth
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 |
|---|---|---|
| Modify cardio-respiratory support to avoid cerebral hypoxiamodification of cardio-respiratory support based on an evidence-based treatment guideline | Other | Monitoring of cerebral oxygenation |
| Treatment as usualMonitoring and treatment according to local guidelines and practice | Other | Treatment as usual |
Primary outcome
Severe brain injury or death
Time frame: From birth to 36 weeks postmenstrual age
A composite of severe brain injury detected on any one of a series of cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age or death at 36 weeks postmenstrual age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Background: PubMed 25569128Hyttel-Sorensen S, Pellicer A, Alderliesten T, Austin T, van Bel F, Benders M, Claris O, Dempsey E, Franz AR, Fumagalli M, Gluud C, Grevstad B, Hagmann C, Lemmers P, van Oeveren W, Pichler G, Plomgaard AM, Riera J, Sanchez L, Winkel P, Wolf M, Greisen G. Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial. BMJ. 2015 Jan 5;350:g7635. doi: 10.1136/bmj.g7635.
- Derived from this study: PubMed 42050627Hansen ML, Olsen MH, Lange T, Gluud C, Haugegaard T, Christensen R, Thabane L, Greisen G, Jakobsen JC; SafeBoosC-III Trial Group. Treatment guided by cerebral oximetry monitoring in extremely preterm infants: a Bayesian analysis of the SafeBoosC-III randomised clinical trial. Trials. 2026 Apr 29;27(1):441. doi: 10.1186/s13063-026-09742-z.
- Derived from this study: PubMed 39444031Rasmussen MIS, Hansen ML, Peters C, Greisen G; SafeBoosC-III Trial Group. Web-based training and certification of clinical staff during the randomised clinical trial SafeBoosC-III. Trials. 2024 Oct 23;25(1):711. doi: 10.1186/s13063-024-08530-x.
- Derived from this study: PubMed 37974280Olsen MH, Hansen ML, Lange T, Gluud C, Thabane L, Greisen G, Jakobsen JC; SafeBoosC-III Trial Group. Detailed statistical analysis plan for a secondary Bayesian analysis of the SafeBoosC-III trial: a multinational, randomised clinical trial assessing treatment guided by cerebral oximetry monitoring versus usual care in extremely preterm infants. Trials. 2023 Nov 16;24(1):737. doi: 10.1186/s13063-023-07720-3.
- Derived from this study: PubMed 37075142Hansen ML, Pellicer A, Hyttel-Sorensen S, Ergenekon E, Szczapa T, Hagmann C, Naulaers G, Mintzer J, Fumagalli M, Dimitriou G, Dempsey E, Tkaczyk J, Cheng G, Fredly S, Heuchan AM, Pichler G, Fuchs H, Nesargi S, Hahn GH, Piris-Borregas S, Sirc J, Alsina-Casanova M, Stocker M, Ozkan H, Sarafidis K, Hopper AO, Karen T, Rzepecka-Weglarz B, Oguz SS, Arruza L, Memisoglu AC, Del Rio Florentino R, Baserga M, Maton P, Truttmann AC, de Las Cuevas I, Agergaard P, Zafra P, Bender L, Lauterbach R, Lecart C, de Buyst J, El-Khuffash A, Curley A, Vaccarello OO, Miletin J, Papathoma E, Vesoulis Z, Vento G, Cornette L, Lopez LS, Yasa B, Klamer A, Agosti M, Baud O, Mastretta E, Cetinkaya M, McCall K, Zeng S, Hatzidaki E, Bargiel A, Marciniak S, Gao X, Huijia L, Chalak L, Yang L, Rao SA, Xu X, Gonzalez BL, Wilinska M, Yin Z, Sadowska-Krawczenko I, Serrano-Vinuales I, Krolak-Olejnik B, Ybarra MM, Morales-Betancourt C, Korcek P, Teresa-Palacio M, Mosca F, Hergenhan A, Koksal N, Tsoni K, Kadri MM, Knopfli C, Rafinska-Wazny E, Akin MS, Nordvik T, Peng Z, Kersin SG, Thewissen L, Alarcon A, Healy D, Urlesberger B, Bas M, Baumgartner J, Skylogianni E, Karadyova V, Valverde E, Bergon-Sendin E, Kucera J, Pisoni S, Wang L, Smits A, Sanchez-Salmador R, Rasmussen MI, Olsen MH, Jensen AK, Gluud C, Jakobsen JC, Greisen G. Cerebral Oximetry Monitoring in Extremely Preterm Infants. N Engl J Med. 2023 Apr 20;388(16):1501-1511. doi: 10.1056/NEJMoa2207554.
- Derived from this study: PubMed 32326953Hansen ML, Rasmussen MI, Rubin S, Pellicer A, Cheng G, Xu X, Zhaoqing Y, Zoffmann V, Greisen G. Pilot test of an online training module on near-infrared spectroscopy monitoring for the randomised clinical trial SafeBoosC-III. Trials. 2020 Apr 23;21(1):356. doi: 10.1186/s13063-020-4206-6.
- Derived from this study: PubMed 31888764Hansen ML, Pellicer A, Gluud C, Dempsey E, Mintzer J, Hyttel-Sorensen S, Heuchan AM, Hagmann C, Ergenekon E, Dimitriou G, Pichler G, Naulaers G, Cheng G, Guimaraes H, Tkaczyk J, Kreutzer KB, Fumagalli M, Claris O, Lemmers P, Fredly S, Szczapa T, Austin T, Jakobsen JC, Greisen G. Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial. Trials. 2019 Dec 30;20(1):811. doi: 10.1186/s13063-019-3955-6.
- Derived from this study: PubMed 31856902Hansen ML, Pellicer A, Gluud C, Dempsey E, Mintzer J, Hyttel-Sorensen S, Heuchan AM, Hagmann C, Dimitriou G, Pichler G, Naulaers G, Cheng G, Vilan A, Tkaczyk J, Kreutzer KB, Fumagalli M, Claris O, Fredly S, Szczapa T, Lange T, Jakobsen JC, Greisen G. 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. Trials. 2019 Dec 19;20(1):746. doi: 10.1186/s13063-019-3756-y.
- Trial websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Gorm Greisen, MD, Prof principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modify cardio-respiratory support to avoid cerebral hypoxia and Treatment as usual in people with Infant, Extremely Premature and Brain Injuries, run by Gorm Greisen at 1 site in Denmark.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 20 Dec 2021. 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 Denmark. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe brain injury or death (time frame: From birth to 36 weeks postmenstrual age). 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 NCT03770741, which also lists 8 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 20 Dec 2021.