Trial reportPediatric research2016
The SafeBoosC II randomized trial: treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury.
Trial report in Pediatric research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 3 of them syntheses that pooled it.
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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.
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Who cites it
37 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Brain oxygenation monitoring during neonatal stabilization and resuscitation and its potential for improving preterm infant outcomes: a systematic review and meta-analysis with Bayesian analysis.European journal of pediatrics · 2025Pooled it
- Fetal Hemoglobin and Tissue Oxygenation Measured With Near-Infrared Spectroscopy-A Systematic Qualitative Review.Frontiers in pediatrics · 2021Pooled it
- Cerebral near-infrared spectroscopy monitoring for prevention of brain injury in very preterm infants.The Cochrane database of systematic reviews · 2017Pooled it
- Multimodal Monitoring of Hemodynamics in Neonates With Extremely Low Gestational Age: A Randomized Clinical Trial.JAMA network open · 2025Trial
- Trial
- No neurodevelopmental benefit of cerebral oximetry in the first randomised trial (SafeBoosC II) in preterm infants during the first days of life.Acta paediatrica (Oslo, Norway : 1992) · 2019Trial
- Early biomarkers of brain injury and cerebral hypo- and hyperoxia in the SafeBoosC II trial.PloS one · 2017Trial
- Oxygen diffusion kinetics, buffering capacity and phenotype: A narrative review of oxygen physiology and later phenotype in very preterm infants.Experimental physiology · 2026Review
- Article
- Cerebral oxygenation in the preterm newborn - what can we do?Pediatric research · 2024Article
- Cerebral near-infrared spectroscopy guided neonatal intensive care management for the preterm infant.Pediatric research · 2024Review
- The role of endothelial frequency in the cerebral blood flow control during neonatal asphyxia: a retrospective longitudinal study.BMC pediatrics · 2024Article
- Predicting the effectiveness of drugs used for treating cardiovascular conditions in newborn infants.Pediatric research · 2024Article
- Early EEG-burst sharpness and 2-year disability in extremely preterm infants.Pediatric research · 2024Article
- Neuromonitoring in neonatal critical care part II: extremely premature infants and critically ill neonates.Pediatric research · 2023Review
- Cerebral oxygenation immediately after birth and long-term outcome in preterm neonates-a retrospective analysis.BMC pediatrics · 2023Article
- Cross-sectional association between red blood cell distribution width and regional cerebral tissue oxygen saturation in preterm infants in the first 14 days after birth.Frontiers in pediatrics · 2023Article
- Association of early cerebral oxygen saturation and brain injury in extremely preterm infants.Journal of perinatology : official journal of the California Perinatal Association · 2022Article
- Prevention of severe brain injury in very preterm neonates: A quality improvement initiative.Journal of perinatology : official journal of the California Perinatal Association · 2022Article
- Multi-laboratory performance assessment of diffuse optics instruments: the BitMap exercise.Journal of biomedical optics · 2022Article
Corrections and comments
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Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe SafeBoosC phase II multicentre randomized clinical trial investigated the benefits and harms of monitoring cerebral oxygenation by near-infrared spectroscopy (NIRS) combined with an evidence-based treatment guideline vs. no NIRS data and treatment as usual in the control group during the first 72 h of life. The trial demonstrated a significant reduction in the burden of cerebral hypoxia in the experimental group. We now report the blindly assessed and analyzed treatment effects on electroencephalographic (EEG) outcomes (burst rate and spectral edge frequency 95% (SEF95)) and blood biomarkers of brain injury (S100β, brain fatty acid-binding protein, and neuroketal).
methodsOne hundred and sixty-six extremely preterm infants were randomized to either experimental or control group. EEG was recorded at 64 h of age and blood samples were collected at 6 and 64 h of age.
resultsOne hundred and thirty-three EEGs were evaluated. The two groups did not differ regarding burst rates (experimental 7.2 vs. control 7.7 burst/min) or SEF95 (experimental 18.1 vs. control 18.0 Hz). The two groups did not differ regarding blood S100β, brain fatty acid-binding protein, and neuroketal concentrations at 6 and 64 h (n = 123 participants).
conclusionTreatment guided by NIRS reduced the cerebral burden of hypoxia without affecting EEG or the selected blood biomarkers.
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