Abstract
Several instruments implementing spatially resolved near-infrared spectroscopy (NIRS) to monitor tissue oxygenation are now approved for clinical use. The neonatal brain is readily assessible by NIRS and neurodevelopmental impairment is common in children who were in need of intensive care during the neonatal period. It is likely that an important part of the burden of this handicap is due to brain injury induced by hypoxia-ischaemia during intensive care. In particular, this is true for infants born extremely preterm. Thus, monitoring of cerebral oxygenation has considerable potential benefit in this group. The benefit, however, should be weighed against the disturbance to the infant, against the limitations imposed on clinical care and against costs. The ultimate way of demonstrating the 'added value' is by a randomized controlled trial. Cerebral oximetry must reduce the risk of a clinically relevant endpoint, such as death or neurodevelopmental handicap. We estimate that such a trial should recruit about 4000 infants to have the power to detect a reduction in brain injury by one-fifth. This illustrates the formidable task of providing first-grade evidence for the clinical value of diagnostic methods. Is it a window of opportunity for the establishment of a rational basis before another technology is added to an already overly complex newborn intensive care?