Trial reportTrials2026
Treatment guided by cerebral oximetry monitoring in extremely preterm infants: a Bayesian analysis of the SafeBoosC-III randomised clinical trial.
Trial report in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03770741 (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), which is not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
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Authors and funding
10 authors.
Funding
Abstract
purposeThe SafeBoosC-III trial compared treatment guided by cerebral oximetry monitoring for the first 72 h after birth with usual care in 1601 extremely preterm infants. Incidence of death or severe brain injury at 36 weeks of postmenstrual age did not differ between the cerebral oximetry and usual care group (relative risk with cerebral oximetry, 1.03; 95% CI 0.90 to 1.18). To assess the probability of clinically important benefit or harm, we conducted secondary analyses in a Bayesian framework.
methodsPrimary analyses used a weakly informative prior assuming a wide range of effects, to assess the probability that treatment guided by cerebral oximetry monitoring carried an a priori defined clinically important benefit or harm (a relative risk below 0.90 or above 1.10) or any benefit or harm (a relative risk differing from 1.0) for death or severe brain injury. Secondary analyses used an evidence-based prior derived from relevant prior trials.
resultsPosterior probabilities of clinically important benefit or harm were 1.5% and 19.2%, respectively. Posterior probabilities of any benefit or harm were 28.7% and 71.3%, respectively. Probabilities derived from secondary analyses using evidence-based priors were consistent with those from the primary analysis.
conclusionTreatment guided by cerebral oximetry monitoring during the first 72 h after birth in extremely preterm infants resulted in posterior probabilities of 1.5% for a clinically important benefit and 19.2% for a clinically important harm with respect to the incidence of death or severe brain injury at 36 weeks of postmenstrual age.
trial registrationClinicalTrials.gov NCT03770741. Registered on 12 July 2018.
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