Pilot intervention trial

​A pilot study, a phase-I trial, was run in Copenhagen during the finalization of the protocol and the funding applications for the phase-II trial.
Although NIRS and cerebral oximetry had been used for many years in the NICU, this had been for research only, and all the work had been done by research fellows. The most important questions were the possibility to obtain parental consent shortly after birth, acceptability of continuous to clinical staff and parents, the quality of recording in daily routine, the clinician’s responses to out-of-range values of cerebral oxygenation, and adverse events. Two different oximeters were used, as determined by their availability.