It is not standard to demand evidence of benefits and harms from randomized clinical trials before taking new patient monitoring methods into clinical use. But partly, there is no gold standard to compare with, simply to claim equivalence, partly, it is self-evident that the placement of another sensor on a small, extremely preterm infants will cause some disturbance and will take some time from clinical staff, in NICUs that are already busy. Furthermore, sensors may injure the skin, and clinical responses to abnormal values may be inappropriate. This means that there is a potential for harm.
A diagnostic method must lead to better treatment to give clinical value and value to patients. For extremely preterm infants during the first days of life, this means more individually-adapted cardio-respiratory support. The clinicians caring for the infants 24/7 must react appropriately. To this end, the SafeBoosC consortium developed a treatment guideline
No evidence was (or is) available in terms of clinical benefit of any particular intervention for cerebral hypoxia or hyperoxia. So evidence came from physiological and pathophysiological research in preterm infants, and the level of evidence was classified according to the GRADE system, which is methodology-independent.
A flow-chart with a sequence of choices was deemed inappropriate, as cardio-respiratory support may be complex, and as the clinician typically face a multitude of diagnostic inputs. Therefore, the guideline is rather a structured list of possibilities to consider, with ‘no action’ as an option.
As the SafeBoosC-II trial showed a low burden of hyperoxia unaffected by monitoring-based interventions, the treatment guideline has been modified for SafeBoosC III and does not target cerebral hyperoxia. Thus, the interventions for hyperoxia have been removed for the SafeBoosC-III trials guideline. An overview of the treatment guideline for SafeBoosC III can be seen below.