The SafeBoosC II randomized trial: treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury

Anne M Plomgaard; Wim van Oeveren; Tue H Petersen; Thomas Alderliesten; Topun Austin; Frank van Bel; Manon Benders; Olivier Claris; Eugene Dempsey; Axel Franz; Monica Fumagalli; Christian Gluud; Cornelia Hagmann; Simon Hyttel-Sorensen; Petra Lemmers; Adelina Pellicer; Gerhard Pichler; Per Winkel; Gorm Greisen

doi:10.1038/pr.2015.266

The SafeBoosC II randomized trial: treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury

Anne M Plomgaard, Wim van Oeveren, Tue H Petersen, Thomas Alderliesten, Topun Austin, Frank van Bel, Manon Benders, Olivier Claris, Eugene Dempsey, Axel Franz, Monica Fumagalli, Christian Gluud, Cornelia Hagmann, Simon Hyttel-Sorensen, Petra Lemmers, Adelina Pellicer, Gerhard Pichler, Per Winkel, Gorm Greisen

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Abstract

BACKGROUND: The SafeBoosC phase II multicentre randomised clinical trial investigated the benefits and harms of monitoring cerebral oxygenation by near-infrared spectroscopy (NIRS) combined with an evidence-based treatment guideline versus no NIRS-data and treatment as usual in the control group during the first 72 hours 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 analysed treatment effects on EEG (burst rate and spectral edge frequency 95%) and blood biomarkers of brain injury (S100β, brain-fatty-acid-binding-protein, and neuroketal).

METHODS: One-hundred-and-sixty-six extremely preterm infants were randomised to either experimental or control group. EEG was recorded at 64 hours of age and blood samples were collected at 6 and 64 hours of age.

RESULTS: One-hundred-and-thirty-three EEGs were evaluated. The two groups did not differ regarding burst rates (experimental 7.2 versus control 7.7 burst/min.) or spectral edge frequency 95% (experimental 18.1 versus control 18.0 Hertz). The two groups did not differ regarding blood S100β, brain-fatty-acid-binding-protein, and neuroketal concentrations at 6 and 64 hours (n=123 participants).

CONCLUSIONS: Treatment guided by near-infrared spectroscopy reduced the cerebral burden of hypoxia without affecting EEG or the selected blood biomarkers.

Original language	English
Pages (from-to)	528–535
Journal	Pediatric Research
Volume	79
DOIs	https://doi.org/10.1038/pr.2015.266
Publication status	Published - 2016

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Plomgaard, A. M., van Oeveren, W., Petersen, T. H., Alderliesten, T., Austin, T., van Bel, F., Benders, M., Claris, O., Dempsey, E., Franz, A., Fumagalli, M., Gluud, C., Hagmann, C., Hyttel-Sorensen, S., Lemmers, P., Pellicer, A., Pichler, G., Winkel, P., & Greisen, G. (2016). The SafeBoosC II randomized trial: treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury. Pediatric Research, 79, 528–535. https://doi.org/10.1038/pr.2015.266

@article{7b72d36e851841c298b4310ab0a70a7c,

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 randomised clinical trial investigated the benefits and harms of monitoring cerebral oxygenation by near-infrared spectroscopy (NIRS) combined with an evidence-based treatment guideline versus no NIRS-data and treatment as usual in the control group during the first 72 hours 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 analysed treatment effects on EEG (burst rate and spectral edge frequency 95%) and blood biomarkers of brain injury (S100β, brain-fatty-acid-binding-protein, and neuroketal).METHODS: One-hundred-and-sixty-six extremely preterm infants were randomised to either experimental or control group. EEG was recorded at 64 hours of age and blood samples were collected at 6 and 64 hours of age.RESULTS: One-hundred-and-thirty-three EEGs were evaluated. The two groups did not differ regarding burst rates (experimental 7.2 versus control 7.7 burst/min.) or spectral edge frequency 95% (experimental 18.1 versus control 18.0 Hertz). The two groups did not differ regarding blood S100β, brain-fatty-acid-binding-protein, and neuroketal concentrations at 6 and 64 hours (n=123 participants).CONCLUSIONS: Treatment guided by near-infrared spectroscopy reduced the cerebral burden of hypoxia without affecting EEG or the selected blood biomarkers.",

author = "Plomgaard, {Anne M} and {van Oeveren}, Wim and Petersen, {Tue H} and Thomas Alderliesten and Topun Austin and {van Bel}, Frank and Manon Benders and Olivier Claris and Eugene Dempsey and Axel Franz and Monica Fumagalli and Christian Gluud and Cornelia Hagmann and Simon Hyttel-Sorensen and Petra Lemmers and Adelina Pellicer and Gerhard Pichler and Per Winkel and Gorm Greisen",

year = "2016",

doi = "10.1038/pr.2015.266",

language = "English",

volume = "79",

pages = "528–535",

journal = "Pediatric Research",

issn = "0031-3998",

publisher = "Lippincott Williams & Wilkins",

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Plomgaard, AM, van Oeveren, W, Petersen, TH, Alderliesten, T, Austin, T, van Bel, F, Benders, M, Claris, O, Dempsey, E, Franz, A, Fumagalli, M, Gluud, C, Hagmann, C, Hyttel-Sorensen, S, Lemmers, P, Pellicer, A, Pichler, G, Winkel, P & Greisen, G 2016, 'The SafeBoosC II randomized trial: treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury', Pediatric Research, vol. 79, pp. 528–535. https://doi.org/10.1038/pr.2015.266

TY - JOUR

T1 - The SafeBoosC II randomized trial

T2 - treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury

AU - Plomgaard, Anne M

AU - van Oeveren, Wim

AU - Petersen, Tue H

AU - Alderliesten, Thomas

AU - Austin, Topun

AU - van Bel, Frank

AU - Benders, Manon

AU - Claris, Olivier

AU - Dempsey, Eugene

AU - Franz, Axel

AU - Fumagalli, Monica

AU - Gluud, Christian

AU - Hagmann, Cornelia

AU - Hyttel-Sorensen, Simon

AU - Lemmers, Petra

AU - Pellicer, Adelina

AU - Pichler, Gerhard

AU - Winkel, Per

AU - Greisen, Gorm

PY - 2016

Y1 - 2016

N2 - BACKGROUND: The SafeBoosC phase II multicentre randomised clinical trial investigated the benefits and harms of monitoring cerebral oxygenation by near-infrared spectroscopy (NIRS) combined with an evidence-based treatment guideline versus no NIRS-data and treatment as usual in the control group during the first 72 hours 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 analysed treatment effects on EEG (burst rate and spectral edge frequency 95%) and blood biomarkers of brain injury (S100β, brain-fatty-acid-binding-protein, and neuroketal).METHODS: One-hundred-and-sixty-six extremely preterm infants were randomised to either experimental or control group. EEG was recorded at 64 hours of age and blood samples were collected at 6 and 64 hours of age.RESULTS: One-hundred-and-thirty-three EEGs were evaluated. The two groups did not differ regarding burst rates (experimental 7.2 versus control 7.7 burst/min.) or spectral edge frequency 95% (experimental 18.1 versus control 18.0 Hertz). The two groups did not differ regarding blood S100β, brain-fatty-acid-binding-protein, and neuroketal concentrations at 6 and 64 hours (n=123 participants).CONCLUSIONS: Treatment guided by near-infrared spectroscopy reduced the cerebral burden of hypoxia without affecting EEG or the selected blood biomarkers.

AB - BACKGROUND: The SafeBoosC phase II multicentre randomised clinical trial investigated the benefits and harms of monitoring cerebral oxygenation by near-infrared spectroscopy (NIRS) combined with an evidence-based treatment guideline versus no NIRS-data and treatment as usual in the control group during the first 72 hours 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 analysed treatment effects on EEG (burst rate and spectral edge frequency 95%) and blood biomarkers of brain injury (S100β, brain-fatty-acid-binding-protein, and neuroketal).METHODS: One-hundred-and-sixty-six extremely preterm infants were randomised to either experimental or control group. EEG was recorded at 64 hours of age and blood samples were collected at 6 and 64 hours of age.RESULTS: One-hundred-and-thirty-three EEGs were evaluated. The two groups did not differ regarding burst rates (experimental 7.2 versus control 7.7 burst/min.) or spectral edge frequency 95% (experimental 18.1 versus control 18.0 Hertz). The two groups did not differ regarding blood S100β, brain-fatty-acid-binding-protein, and neuroketal concentrations at 6 and 64 hours (n=123 participants).CONCLUSIONS: Treatment guided by near-infrared spectroscopy reduced the cerebral burden of hypoxia without affecting EEG or the selected blood biomarkers.

U2 - 10.1038/pr.2015.266

DO - 10.1038/pr.2015.266

M3 - Article

C2 - 26679155

SN - 0031-3998

VL - 79

SP - 528

EP - 535

JO - Pediatric Research

JF - Pediatric Research

ER -

The SafeBoosC II randomized trial: treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury

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