Safeguarding the Brain of Our Smallest Infants Phase III
NCT ID: NCT03770741
Last Updated: 2021-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1601 participants
INTERVENTIONAL
2019-06-20
2021-12-16
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Monitoring of cerebral oxygenation
Modify cardio-respiratory support to avoid cerebral hypoxia
Modify cardio-respiratory support to avoid cerebral hypoxia
modification of cardio-respiratory support based on an evidence-based treatment guideline
Treatment as usual
Treatment according local guidelines and practices.
Treatment as usual
Monitoring and treatment according to local guidelines and practice
Interventions
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Modify cardio-respiratory support to avoid cerebral hypoxia
modification of cardio-respiratory support based on an evidence-based treatment guideline
Treatment as usual
Monitoring and treatment according to local guidelines and practice
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent, unless the NICU has chosen to use 'opt-out' or deferred consent as consent method.
Exclusion Criteria
* No possibility to place cerebral NIRS oximeter within six hours after birth
6 Hours
ALL
No
Sponsors
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Copenhagen Trial Unit, Center for Clinical Intervention Research
OTHER
Elsass Foundation
OTHER
Gorm Greisen
OTHER
Responsible Party
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Gorm Greisen
Professor in Pediatrics
Principal Investigators
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Gorm Greisen, MD, Prof
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Rigshospitalet
Copenhagen, , Denmark
Countries
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References
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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.
Rasmussen 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.
Olsen 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.
Hansen 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.
Hansen 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.
Hansen 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.
Hansen 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.
Related Links
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Trial website
Other Identifiers
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SafeBoosC-DP-363
Identifier Type: -
Identifier Source: org_study_id