No neurodevelopmental benefit of cerebral oximetry in the first randomised trial (SafeBoosC II) in preterm infants during the first days of life
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Date
2018
Authors
Plomgaard, Anne M.
Alderliesten, Thomas
van Bel, Frank
Benders, Manon
Claris, Olivier
Cordeiro, Malaika
Dempsey, Eugene M.
Fumagalli, Monica
Gluud, Christian
Hyttel-Sorensen, Simon
Journal Title
Journal ISSN
Volume Title
Publisher
Wiley, Blackwell Publishing Ltd
Published Version
Abstract
Aim: Cerebral hypoxia has been associated with neurodevelopmental impairment. We studied whether reducing cerebral hypoxia in extremely preterm infants during the first 72 hours of life affected neurological outcomes at two years of corrected age. Methods: In 2012‐2013, the phase II randomised Safeguarding the Brains of our smallest Children trial compared visible cerebral near‐infrared spectroscopy (NIRS) monitoring in an intervention group and blinded NIRS monitoring in a control group. Cerebral hy oxia was significantly reduced in the intervention group. We followed up 115 survivors from eight European centres at two years of corrected age, by conducting a medical examination and assessing their neurodevelopment with the Bayley Scales of Infant and Toddler Development, Second or Third Edition, and the parental Ages and Stages Questionnaire (ASQ). Results: There were no differences between the intervention (n = 65) and control (n = 50) groups with regard to the mean mental developmental index (89.6 ± 19.5 versus 88.4 ± 14.7, p = 0.77), ASQ score (215 ± 58 versus 213 ± 58, p = 0.88) and the number of children with moderate‐to‐severe neurodevelopmental impairment (10 versus six, p = 0.58). Conclusions: Cerebral NIRS monitoring was not associated with long‐term benefits or harm with regard to neurodevelopmental outcome at two years of corrected age.
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Keywords
Ages and stages questionnaire , bayley scales of infant and toddler development , cerebral near‐infrared spectroscopy , extremely preterm infants , neurodevelopment
Citation
Plomgaard, A. M., Alderliesten, T., van Bel, F., Benders, M., Claris, O., Cordeiro, M., Dempsey, E., Fumagalli, M., Gluud, C., Hyttel-Sorensen, S., Lemmers, P., Pellicer, A., Pichler, G. and Greisen, G. 'No neurodevelopmental benefit of cerebral oximetry in the first randomised trial (SafeBoosC II) in preterm infants during the first days of life', Acta Paediatrica. pp. 1-7. doi: 10.1111/apa.14463