​Below you will find all publications from the SafeBoosC project, listed in chronological order.

  1. The ideas behind the SafeBoosC trial and improved instrumentation (full text, open access)

  2. Testing of the performance of three commercial oximeters and a university-developed prototype (full text, open access)

  3. A pilot trial of the Oximeter-visible arm in 10 patients (full text, open access)

  4. Phase-II trial protocol publication (full text, open access)

  5. The SafeBoocS Phase II Randomised Clinical Trial:
    A Treatment Guideline for Targeted Near-Infrared-Derived Cerebral Tissue Oxygenation versus Standard Treatment in Extremely Preterm Infants (full text, open access)

  6. An in-vitro study comparing three commercial NIRS oximeters and the OxyPrem, the protype instrument of the SafeBoosC project (full text, open access)

  7. The rate of oxygenation in the minutes after birth differs as monitored by two commercial NIRS oximeters (full text, open access)

  8. The results of the SafeBoosC phase-II trial as regards the primary outcome - the burden of cerebral hypo-and hyper oxygenation . The burden was reduced to less than half (BMJ paper open access)

  9. Comparison of the prototype oximeter OxyPrem and the INVOS oximeter on the adult forarm and the term newborn head in the minutes after birth (full text, open access​)

  10. An analysis of the brain imaging done in the SafeBoosC-II trial. There was no reduction in brain injury in the experimental group compared to the control group. The largest difference between the groups were in the cerebral ultrasound data obtained during the first four days of life. At term corrected age a significant proportion of the infants did not have the planned examinations by cerebral ultrasound or by magnetic resonance imaging (full text, open access​)

  11. An analysis of the response to the alarms of the cerebral oximeter in the experimental group of the SafeBoosC-II trial. More than 50% of times, nothing was done, while 50% of interventions consisted of dialing the FiO2, i.e. using the cerebral oximeter as a supplement to the pulseoximeter. But in the remaining situations a range of clinical interventions were chosen that may well have influenced brain blood flow and hence monitoring of cerebral oxygenation may genuinely have contributed to the quality of intensive care (full text, open access)

  12. A second blood-lipid phantom study that demonstrated a quite stable relation between continuous-wave devices and a frequency-domain device when scattering is changed, but strong influence by changes in haemoglobin concentration at low levels of oxygenation. This may be important for the choice of the threshold for clinical intervention to reduce cerebral hypoxia ​(full text, open access)

  13. The reduction in the burden of cerebral hypoxia in the experimental arm of the SafeBoosC-II trial was not accompanied by a reduction in evidence of brain injury as assessed by cerebral ultrasound, aEEG, and molecular biomarkers in peripheral blood ​(full text, open access)

  14. Cerebral oximetry in preterm infants - an agenda for research with a clear clinical goal: A review of clinical research using NIRS for cerebral oximetry in preterm infants with a focus on the research required to make it clinical routine. (full text, open access​)

  15. An experiment with a refined blood-lipid phantom to compare the readings of different commercial oximeters and a revised version of the OxyPrem prototype. Value​s are provided that correspond to the 55% cerebral hypoxia threshold as defined by the INVOS 5100 with the adult sensor (full text, open access​)

  16. Uncertainty as regards the clinical value, also called equipoise, is important for the clinician that informs parents in order to obtain consent for randomizing their child for a placebo controlled clinical trial. Testing a new intervention is likely to be easier than testing an intervention that is already in clinical use in spite of lack of good evidence for its value (full text, open access)

  17. An analysis of the relation between cerebral hypoxia and cerebral hyperoxia and the early markers of brain injury. The analysis was not based on the randomization groups, and hence is observational. Cerebral hypoxia was associated with low EEG burst rate, severe brain injury, and death, but not with the molecular biomarkers of brain injury as measured in blood. Cerebral hypoxia was not clearly associated with outcomes (full text, open access)

  18. An extension of the work on standardisation of cerebral oximeters for newborn using a blood-lipid phantom (full text, open access)

  19. The phd-thesis of Simon Hyttel-Sørensen on NIRS based tissue oximetry (full text)

  20. The phd-thesis of Anne Mette Plomgaard on the effects of cerebral hypo-and hyperoxia (full text)

  21. At two years of age there was no neurodevelopmental advantage in the NIRS open group (full text) The statistical power, however, is insufficient to exclude important clinical benefits. 

  22. A new version of the OxyPrem prototype instrument with light sources and detectors on a line rather than in a hexagonal arrangement has been developed. Version 1.3 was tested on the heads of stable preterm infants and an improved precision was found (full text

  23. The SafeBoosC-III trial protocol publication (full text, open access)

  24. The SafeBoosC-III statistical analysis publication (full text, open access)

  25. Comparison of two oximeters in preterm infants with spontaneous apnea confirms that different devices gives different estimates when the oxygenation is low (full text)

  26. A pilot study of an online training module on cerebral NIRS monitoring, to evaluate the feasibility of, and enhance the SafeBoosC-III web-based training and certification program (full text, open access)

  27. The protocol publication for the systematic review with meta-analysis evaluating the benefits and harms of cerebral NIRS monitoring versus no monitoring in children and adults across all clinical settings (full text)

  28. An in-vitro phantom study evaluating the effect of not removing the glossy white cover from adhesive INVOS neonatal sensors on oxygenation measurements (full text)  

  29. A retrospective observational study, evaluating if the number of admitted extremely preterm infants differed in the neonatal intensive care units of the SafeBoosC-III consortium during the global COVID-19 lockdown in the spring of 2020, when compared to the corresponding time period in 2019 (full text, open access)

  30. Publication of the time-effective central data monitoring approach for the SafeBoosC-III trial, including the results and consequences following the first three central data monitoring meetings (full text, open access)

  31. A discussion on conflicting results, publication ethics, and publication bias, based on two publications – one from the SafeBoosCIII consortium - on the impact of the COVID pandemic on prematurity rate (full text, open access)

  32. A discussion on the reliability of cerebral oximetry measurements, the pathophysiological rationale behind the clinical use, the evidence on benefits and harms, and the costs (full text, open access​)​

  33. A systematic review with meta-analysis and trial sequential analysis on the benefits and harms of cerebral NIRS monitoring in children and adults (full text, open access​)​

  34. An analysis of the association between a high burden of cerebral hypoxia and the Bayley MDI and neurodevelopmental deficit at two years (open access, full text​)​