Treatment guided by cerebral oximetry in newborns receiving invasive mechanical ventilation: study protocol for step one of the SafeBoosC-IIIv randomised clinical trial

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dc.contributor.authorKamp, Caroline Barkholt
dc.contributor.authorPetersen, Johanne Juul
dc.contributor.authorHansen, Mathias Lühr
dc.contributor.authorPellicer, Adelina
dc.contributor.authorNaulaers, Gunnar
dc.contributor.authorDempsey, Eugene
dc.contributor.authorHahn, Gitte Holst
dc.contributor.authorOlsen, Markus Harboe
dc.contributor.authorRasmussen, Marie Isabel Skov
dc.contributor.authorPichler, Gerhard
dc.contributor.authorDimitriou, Gabriel
dc.contributor.authorSzczapa, Tomasz
dc.contributor.authorOgnean, Maria Livia
dc.contributor.authorNesargi, Saudamini
dc.contributor.authorMusante, Gabriel
dc.contributor.authorChalak, Lina
dc.contributor.authorDi Maio, Massimo
dc.contributor.authorLakhwani, Jyoti
dc.contributor.authorProcianoy, Renato S
dc.contributor.authorTkaczyk, Jakub
dc.contributor.authorFuchs, Hans
dc.contributor.authorCetinkaya, Merih
dc.contributor.authorHagmann, Cornelia
dc.contributor.authorPopat, Himanshu
dc.contributor.authorFabres, Jorge
dc.contributor.authorWang, Laishuan
dc.contributor.authorSchmölzer, Georg
dc.contributor.authorFumagalli, Monica
dc.contributor.authorPiris-Borregas, Salvador
dc.contributor.authorMohora, Ramona
dc.contributor.authorZafra, Pamela
dc.contributor.authorSarafidis, Kosmas
dc.contributor.authorAlsina-Casanova, Miguel
dc.contributor.authorBaik-Schneditz, Nariae
dc.contributor.authorLopez, Laura Serrano
dc.contributor.authorGriesmaier, Elke
dc.contributor.authorHatzidaki, Eleftheria
dc.contributor.authorA, Shashidhar
dc.contributor.authorDassios, Theodore
dc.contributor.authorGreisen, Gorm
dc.contributor.authorJakobsen, Janus Christian
dc.contributor.funderIndependent Research Fund Denmark
dc.date.accessioned2026-07-03T13:50:03Z
dc.date.available2026-07-03T13:50:03Z
dc.date.issued2026-03-17
dc.description© 2026. The Author(s). Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.
dc.description.abstractBACKGROUND: The use of invasive mechanical ventilation in newborns has several risks, including ventilator-induced lung injury, ventilation-associated pneumonia, and hyperventilation leading to potential brain injury, prolonged hospitalisations, and increased mortality. The SafeBoosC-IIIv trial aims to assess the benefits and harms of treatment guided by cerebral oximetry monitoring in newborns receiving invasive mechanical ventilation within the first 28 days from birth. The SafeBoosC consortium is a global network of neonatologists from multiple neonatal intensive care units worldwide. METHODS: The SafeBoosC-IIIv trial is an investigator-initiated, multinational, randomised, pragmatic, superiority phase III clinical trial. The trial will be conducted in two steps. This is a protocol for step one. The objective of step one is to assess if treatment guided by cerebral oximetry monitoring according to the SafeBoosC treatment guideline compared with usual care in newborns receiving invasive mechanical ventilation increases the number of hospital-free days. The participants will be newborns with a gestational age more than or equal to 28 + 0 weeks, postnatal age less than 28 days, expected to receive invasive mechanical ventilation (intubation) for at least 24 h, and a cerebral oximeter available so monitoring can be started within 6 h after initiation of invasive mechanical ventilation. Exclusion criteria will be suspicion of or confirmed brain injury or congenital heart malformation likely to require surgery. A total of 1,610 participants will be randomised 1:1 to treatment guided by cerebral oximetry monitoring or usual care. The primary outcome will be hospital-free days, and the secondary outcomes will be serious adverse events and invasive mechanical ventilation-free days. All outcomes will be assessed at 90 days after randomisation. DISCUSSION: The SafeBoosC-IIIv trial has several strengths, including detailed predefined methodology, a high degree of external validity due to centres in several countries, and the trial will be built upon the already established SafeBoosC consortium and the experience from the previous SafeBoosC-II and SafeBoosC-III trials. The SafeBoosC-IIIv trial has limitations, including current lack of funding for step two, lack of blinding of the clinical staff, and the clinicians may have limited experience in using the device. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05907317, registered 8 June 2023, https://clinicaltrials.gov/study/NCT05907317?cond=NCT05907317&rank=1.en
dc.description.sponsorshipIndependent Research Fund Denmark|SafeBoosC‑IIIv trial
dc.format.extent11
dc.format.extent1401217
dc.identifier.articleid318
dc.identifier.authororcidKamp, Caroline Barkholt
dc.identifier.authororcidPetersen, Johanne Juul
dc.identifier.authororcidHansen, Mathias Lühr
dc.identifier.authororcidPellicer, Adelina
dc.identifier.authororcidNaulaers, Gunnar
dc.identifier.authororcidDempsey, Eugene§0000-0002-6266-3462
dc.identifier.authororcidHahn, Gitte Holst
dc.identifier.authororcidOlsen, Markus Harboe
dc.identifier.authororcidRasmussen, Marie Isabel Skov
dc.identifier.authororcidPichler, Gerhard
dc.identifier.authororcidDimitriou, Gabriel
dc.identifier.authororcidSzczapa, Tomasz
dc.identifier.authororcidOgnean, Maria Livia
dc.identifier.authororcidNesargi, Saudamini
dc.identifier.authororcidMusante, Gabriel
dc.identifier.authororcidChalak, Lina
dc.identifier.authororcidDi Maio, Massimo
dc.identifier.authororcidLakhwani, Jyoti
dc.identifier.authororcidProcianoy, Renato S
dc.identifier.authororcidTkaczyk, Jakub
dc.identifier.authororcidFuchs, Hans
dc.identifier.authororcidCetinkaya, Merih
dc.identifier.authororcidHagmann, Cornelia
dc.identifier.authororcidPopat, Himanshu
dc.identifier.authororcidFabres, Jorge
dc.identifier.authororcidWang, Laishuan
dc.identifier.authororcidSchmölzer, Georg
dc.identifier.authororcidFumagalli, Monica
dc.identifier.authororcidPiris-Borregas, Salvador
dc.identifier.authororcidMohora, Ramona
dc.identifier.authororcidZafra, Pamela
dc.identifier.authororcidSarafidis, Kosmas
dc.identifier.authororcidAlsina-Casanova, Miguel
dc.identifier.authororcidBaik-Schneditz, Nariae
dc.identifier.authororcidLopez, Laura Serrano
dc.identifier.authororcidGriesmaier, Elke
dc.identifier.authororcidHatzidaki, Eleftheria
dc.identifier.authororcidA, Shashidhar
dc.identifier.authororcidDassios, Theodore
dc.identifier.authororcidGreisen, Gorm
dc.identifier.authororcidJakobsen, Janus Christian
dc.identifier.citationKamp, C B, Petersen, J J, Hansen, M L, Pellicer, A, Naulaers, G, Dempsey, E, Hahn, G H, Olsen, M H, Rasmussen, M I S, Pichler, G, Dimitriou, G, Szczapa, T, Ognean, M L, Nesargi, S, Musante, G, Chalak, L, Di Maio, M, Lakhwani, J, Procianoy, R S, Tkaczyk, J, Fuchs, H, Cetinkaya, M, Hagmann, C, Popat, H, Fabres, J, Wang, L, Schmölzer, G, Fumagalli, M, Piris-Borregas, S, Mohora, R, Zafra, P, Sarafidis, K, Alsina-Casanova, M, Baik-Schneditz, N, Lopez, L S, Griesmaier, E, Hatzidaki, E, A, S, Dassios, T, Greisen, G & Jakobsen, J C 2026, 'Treatment guided by cerebral oximetry in newborns receiving invasive mechanical ventilation: study protocol for step one of the SafeBoosC-IIIv randomised clinical trial', Trials, vol. 27, no. 1, 318 , pp. 1-11. https://doi.org/10.1186/s13063-026-09631-5
dc.identifier.doi10.1186/s13063-026-09631-5
dc.identifier.endpage11
dc.identifier.issn1468-6708
dc.identifier.issued1
dc.identifier.journaltitleTrials
dc.identifier.otherPubMedCentral: PMC13107782
dc.identifier.startpage1
dc.identifier.urihttps://hdl.handle.net/10468/18994
dc.identifier.volume27
dc.language.isoeng
dc.rightscc_by
dc.subjectSDG 3 - Good Health and Well-being
dc.subjectHumans
dc.subjectOximetry/methods
dc.subjectInfant, newborn
dc.subjectRespiration, artificial/adverse effects
dc.subjectMulticenter studies as topic
dc.subjectPragmatic clinical trials as topic
dc.subjectEquivalence trials as topic
dc.subjectTreatment outcome
dc.subjectRandomized controlled trials as topic
dc.subjectIntensive Care Units, neonatal
dc.subjectCerebrovascular circulation
dc.subjectPredictive value of tests
dc.subject[Medicine]
dc.titleTreatment guided by cerebral oximetry in newborns receiving invasive mechanical ventilation: study protocol for step one of the SafeBoosC-IIIv randomised clinical trialen
dc.typeArticle (Peer reviewed)
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