title: The SafeBoosC II randomized trial: treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury.
abstract: BACKGROUND
  The SafeBoosC phase II multicentre randomized clinical trial investigated the benefits and harms of monitoring cerebral oxygenation by near-infrared spectroscopy (NIRS) combined with an evidence-based treatment guideline vs. no NIRS data and treatment as usual in the control group during the first 72 h of life. The trial demonstrated a significant reduction in the burden of cerebral hypoxia in the experimental group. We now report the blindly assessed and analyzed treatment effects on electroencephalographic (EEG) outcomes (burst rate and spectral edge frequency 95% (SEF95)) and blood biomarkers of brain injury (S100β, brain fatty acid-binding protein, and neuroketal).
  
  
  METHODS
  One hundred and sixty-six extremely preterm infants were randomized to either experimental or control group. EEG was recorded at 64 h of age and blood samples were collected at 6 and 64 h of age.
  
  
  RESULTS
  One hundred and thirty-three EEGs were evaluated. The two groups did not differ regarding burst rates (experimental 7.2 vs. control 7.7 burst/min) or SEF95 (experimental 18.1 vs. control 18.0 Hz). The two groups did not differ regarding blood S100β, brain fatty acid-binding protein, and neuroketal concentrations at 6 and 64 h (n = 123 participants).
  
  
  CONCLUSIONS
  Treatment guided by NIRS reduced the cerebral burden of hypoxia without affecting EEG or the selected blood biomarkers.
authors.affiliation: Department of Neonatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Anne M
authors.initials: AM
authors.lastname: Plomgaard
authors.affiliation: HaemoScan B.V., Groningen, The Netherlands.
authors.forename: Wim
authors.initials: W
authors.lastname: van Oeveren
authors.affiliation: Research Unit on Brain Injury Neurorehabilitation Copenhagen, Department of Neurorehabilitation, TBI Unit, Rigshospitalet, Copenhagen University Hospital, Hvidovre, Denmark.
authors.forename: Tue H
authors.initials: TH
authors.lastname: Petersen
authors.affiliation: Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Thomas
authors.initials: T
authors.lastname: Alderliesten
authors.affiliation: Rosie Maternity Hospital Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
authors.forename: Topun
authors.initials: T
authors.lastname: Austin
authors.affiliation: Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Frank
authors.initials: F
authors.lastname: van Bel
authors.affiliation: Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Manon
authors.identifier: http://orcid.org/0000-0001-5491-9168
authors.initials: M
authors.lastname: Benders
authors.affiliation: Department of Neonatology, Hospital Femme Mere Enfants, Bron, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Claris
authors.affiliation: INFANT Centre, University College Cork, Cork, Ireland.
authors.forename: Eugene
authors.initials: E
authors.lastname: Dempsey
authors.affiliation: Department of Neonatology, University of Tuebingen, Tübingen, Germany.
authors.forename: Axel
authors.identifier: http://orcid.org/0000-0001-5066-0857
authors.initials: A
authors.lastname: Franz
authors.affiliation: NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
authors.forename: Monica
authors.initials: M
authors.lastname: Fumagalli
authors.affiliation: Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
authors.affiliation: Department of Neonatology, University of Zurich, Zurich, Switzerland.
authors.forename: Cornelia
authors.initials: C
authors.lastname: Hagmann
authors.affiliation: Department of Neonatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Simon
authors.initials: S
authors.lastname: Hyttel-Sorensen
authors.affiliation: Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Petra
authors.initials: P
authors.lastname: Lemmers
authors.affiliation: Department of Neonatology, La Paz University Hospital, Madrid, Spain.
authors.forename: Adelina
authors.initials: A
authors.lastname: Pellicer
authors.affiliation: Department of Pediatrics, Medical University of Graz, Graz, Austria.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Pichler
authors.affiliation: Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Per
authors.initials: P
authors.lastname: Winkel
authors.affiliation: Department of Neonatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Gorm
authors.initials: G
authors.lastname: Greisen
mesh_terms: D015415:Biomarkers / Q000378:metabolism*; D001930:Brain Injuries / Q000378:metabolism*; D004569:Electroencephalography; D006801:Humans; D002534:Hypoxia, Brain / Q000378:metabolism / Q000503:physiopathology / Q000517:prevention & control*; D007231:Infant, Newborn; D019265:Spectroscopy, Near-Infrared / Q000379:methods*
chemical_list: D015415:Biomarkers