Brain injury in the international multicenter randomized SafeBoosC phase II feasibility trial: Cranial ultrasound and magnetic resonance imaging assessments

Anne M. Plomgaard, Cornelia Hagmann, Thomas Alderliesten, Topun Austin, Frank Van Bel, Olivier Claris, Eugene Dempsey, Axel Franz, Monica Fumagalli, Christian Gluud, Gorm Greisen, Simon Hyttel-Sorensen, Petra Lemmers, Adelina Pellicer, Gerhard Pichler, Manon Benders

Research output: Contribution to journalArticle

Abstract

Background:Abnormal cerebral perfusion during the first days of life in preterm infants is associated with higher grades of intraventricular hemorrhages 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 magnetic resonance imaging (MRI), (iii) local and central cUS assessment.Methods:Hundred and sixty-six extremely preterm infants were included. cUS was scheduled for day 1, 4, 7, 14, and 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 vs. 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.Conclusion: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 72 h of life prevents brain injury should be evaluated in larger multicenter trials.

Original languageEnglish
Pages (from-to)466-472
Number of pages7
JournalPediatric Research
Volume79
Issue number3
DOIs
Publication statusPublished - Mar 1 2016

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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