Brain injury in the international multicentre randomised SafeBoosC phase II feasibility trial: cranial ultrasound and magnetic resonance imaging assessments

Abstract

BACKGROUND: Abnormal cerebral perfusion during the first days of life in preterm infants is associated with higher grades of intraventricular haemorrhages and lower developmental-score. In SafeBoosC II, we obtained a significant reduction of cerebral hypoxia by monitoring cerebral oxygenation in combination with a treatment guideline. Here we describe (i) difference in brain injury between groups, (ii) feasibility of serial cranial ultrasound (cUS) and MRI, (iii) local and central cUS-assessment. METHODS: 166 extremely preterm infants were included. cUS was scheduled for day 1,4,7,14,35 and at term-equivalent age (TEA). cUS was assessed locally (unblinded) and centrally (blinded). MRI at TEA was assessed centrally (blinded). Brain injury classification: no, mild/moderate, or severe. RESULTS: Severe brain injury did not differ significantly between groups: cUS (experimental 10/80, control 18/77, p=0.32) and MRI (5/46 versus 3/38, p=0.72). Kappa-values for local and central readers were moderate-to-good for severe and poor-to-moderate for mild/moderate injuries. At TEA cUS and MRI were assessed in 72% and 64% respectively. CONCLUSIONS: There was no difference in severe brain injury between groups. Acquiring cUS and MRI according the standard-operating-procedures must be improved for future trials. Whether monitoring cerebral oxygenation during the first 72hours of life prevents brain injury, should be evaluated in larger multicentre trials.Pediatric Research (2015); doi:10.1038/pr.2015.239.