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1. No neurodevelopmental benefit of cerebral oximetry in the first randomised trial (SafeBoosC II) in preterm infants during the first days of life

Author

Plomgaard, Anne M, Alderliesten, Thomas, van Bel, Frank, Benders, Manon, Claris, Olivier, Cordeiro, Malaika, Dempsey, Eugene, Fumagalli, Monica, Gluud, Christian, Hyttel-Sørensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, Greisen, Gorm, Plomgaard, Anne M, Alderliesten, Thomas, van Bel, Frank, Benders, Manon, Claris, Olivier, Cordeiro, Malaika, Dempsey, Eugene, Fumagalli, Monica, Gluud, Christian, Hyttel-Sørensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, and Greisen, Gorm

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 hypoxia 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).CONCLUSION: Cerebral NIRS monitoring was not associated with long-term benefits or harm with regard to neurodevelopmental outcome at two years of corrected age.

Published
2019

2. No neurodevelopmental benefit of cerebral oximetry in the first randomised trial (SafeBoosC II) in preterm infants during the first days of life

Author

Arts-assistenten Kinderen, MS Neonatologie, Child Health, Brain, Regenerative Medicine and Stem Cells, Plomgaard, Anne M., Alderliesten, Thomas, van Bel, Frank, Benders, Manon, Claris, Olivier, Cordeiro, Malaika, Dempsey, Eugene, Fumagalli, Monica, Gluud, Christian, Hyttel-Sorensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, Greisen, Gorm, Arts-assistenten Kinderen, MS Neonatologie, Child Health, Brain, Regenerative Medicine and Stem Cells, Plomgaard, Anne M., Alderliesten, Thomas, van Bel, Frank, Benders, Manon, Claris, Olivier, Cordeiro, Malaika, Dempsey, Eugene, Fumagalli, Monica, Gluud, Christian, Hyttel-Sorensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, and Greisen, Gorm

Published
2019

3. No neurodevelopmental benefit of cerebral oximetry in the first randomised trial (SafeBoosC II) in preterm infants during the first days of life

Author

Plomgaard, Anne M., primary, Alderliesten, Thomas, additional, van Bel, Frank, additional, Benders, Manon, additional, Claris, Olivier, additional, Cordeiro, Malaika, additional, Dempsey, Eugene, additional, Fumagalli, Monica, additional, Gluud, Christian, additional, Hyttel-Sorensen, Simon, additional, Lemmers, Petra, additional, Pellicer, Adelina, additional, Pichler, Gerhard, additional, and Greisen, Gorm, additional

Published
2018
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4. Early biomarkers of brain injury and cerebral hypo- and hyperoxia in the SafeBoosC II trial

Author

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

Published
2017

5. Early biomarkers of brain injury and cerebral hypo- and hyperoxia in the SafeBoosC II trial

Author

Arts-assistenten Kinderen, MS Neonatologie, Brain, Child Health, Regenerative Medicine and Stem Cells, Plomgaard, Anne M, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Fumagalli, Monica, Gluud, Christian, Hagmann, Cornelia, Hyttel-Sorensen, Simon, Lemmers, Petra, van Oeveren, Wim, Pellicer, Adelina, Petersen, Tue H, Pichler, Gerhard, Winkel, Per, Greisen, Gorm, Arts-assistenten Kinderen, MS Neonatologie, Brain, Child Health, Regenerative Medicine and Stem Cells, Plomgaard, Anne M, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Fumagalli, Monica, Gluud, Christian, Hagmann, Cornelia, Hyttel-Sorensen, Simon, Lemmers, Petra, van Oeveren, Wim, Pellicer, Adelina, Petersen, Tue H, Pichler, Gerhard, Winkel, Per, and Greisen, Gorm

Published
2017

6. Early biomarkers of brain injury and cerebral hypo- and hyperoxia in the SafeBoosC II trial

Author

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

Abstract

Background The randomized clinical trial, SafeBoosC II, examined the effect of monitoring of cerebral oxygenation by near-infrared spectroscopy combined with a guideline on treatment when cerebral oxygenation was out of the target range. Data on cerebral oxygenation was collected in both the intervention and the control group. The primary outcome was the reduction in the burden of cerebral hypo- and hyperoxia between the two groups. In this study we describe the associations between the burden of cerebral hypo- and hyperoxia, regardless of allocation to intervention or control group, and the biomarkers of brain injury from birth till term equivalent age that was collected as secondary and explorative outcomes in the SafeBoosC II trial. Methods Cerebral oxygenation was continuously monitored during the first 72h of life in 166 extremely preterm infants. Cranial ultrasound was performed at day 1,4,7,14, and 35 and at term. Electroencephalogram (EEG) was recorded at 64h. Blood-samples taken at 6 and 64 hours were analysed for the brain injury biomarkers; S100beta, brain-fatty-acid-binding-protein, and neuroketal. All analyses were conducted post hoc. Results Significantly more infants with a cerebral burden of hypoxia within the 4th quartile versus infants within quartile 1-3 were diagnosed with severe intracranial haemorrhage (11/39 versus 11/117, p = 0.003), had low burst rate on EEG (12/28 versus 21/103, p = 0.015), or died (14/41 versus 18/123, p = 0.006), whereas none of these events were significantly associated with cerebral hyperoxia. The blood biomarkers were not significantly associated with the burden of cerebral hypo- or hyperoxia. Conclusions The explorative analysis showed that early burden of cerebral hypoxia, but not hyperoxia was significantly associated with low brain electrical activity and severe intracranial haemorrhage while none of the three blood biomarkers were associated with the burden of either cerebral hypo- or hyperoxia.

Published
2017

7. Early biomarkers of brain injury and cerebral hypo- and hyperoxia in the SafeBoosC II trial

Author

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

Published
2017
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8. No neurodevelopmental benefit of cerebral oximetry in the first randomised trial (SafeBoosC II) in preterm infants during the first days of life.

Author

Plomgaard, Anne M., Alderliesten, Thomas, van Bel, Frank, Benders, Manon, Claris, Olivier, Cordeiro, Malaika, Dempsey, Eugene, Fumagalli, Monica, Gluud, Christian, Hyttel‐Sorensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, Greisen, Gorm, and Hyttel-Sorensen, Simon

Subjects
*OXIMETRY, *CEREBRAL anoxia, *CEREBROVASCULAR disease, *OXYGEN in the body, *PREMATURE infants
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 hypoxia 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).Conclusion: Cerebral NIRS monitoring was not associated with long-term benefits or harm with regard to neurodevelopmental outcome at two years of corrected age. [ABSTRACT FROM AUTHOR]

Published
2019
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9. The SafeBoosC II randomized trial:treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury

Author

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

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).CONCLUSION: Treatment guided by NIRS reduced the cerebral burden of hypoxia without affecting EEG or the selected blood biomarkers.

Published
2016

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

Author

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

Published
2016

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

Author

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

Published
2016

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

Author

MS Neonatologie, Brain, Regenerative Medicine and Stem Cells, Plomgaard, Anne M, Hagmann, Cornelia, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Claris, Olivier, Dempsey, Eugene, Franz, Axel, Fumagalli, Monica, Gluud, Christian, Greisen, Gorm, Hyttel-Sorensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, Benders, Manon, MS Neonatologie, Brain, Regenerative Medicine and Stem Cells, Plomgaard, Anne M, Hagmann, Cornelia, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Claris, Olivier, Dempsey, Eugene, Franz, Axel, Fumagalli, Monica, Gluud, Christian, Greisen, Gorm, Hyttel-Sorensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, and Benders, Manon

Published
2016

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

Author

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

Published
2016

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

Author

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

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.

Published
2016

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

Author

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

Published
2015
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16. Brain injury in the international multicenter randomized SafeBoosC phase II feasibility trial: cranial ultrasound and magnetic resonance imaging assessments

Author

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

Published
2015
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17. The SafeBoosC II randomized trial: treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury

Author

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

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 (S100ß, 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 S100ß, brain fatty acid-binding protein, and neuroketal concentrations at 6 and 64 h (n = 123 participants).Conclusion:Treatment guided by NIRS reduced the cerebral burden of hypoxia without affecting EEG or the selected blood biomarkers.

Published
2016
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18. The SafeBoosC II randomized trial: treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury

Author

Topun Austin, Christian Gluud, Simon Hyttel-Sorensen, Monica Fumagalli, Gerhard Pichler, Eugene M. Dempsey, Petra M A Lemmers, Adelina Pellicer, Axel R. Franz, Thomas Alderliesten, Wim van Oeveren, Cornelia Hagmann, Per Winkel, Gorm Greisen, Tue Hvass Petersen, Frank van Bel, Manon J.N.L. Benders, Olivier Claris, Anne Mette Plomgaard, University of Zurich, and Plomgaard, Anne M

Subjects
medicine.medical_specialty, Pathology, 610 Medicine & health, Research Support, law.invention, Infant, newborn, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, 030225 pediatrics, Internal medicine, Journal Article, Medicine, Humans, Clinical Investigation, 2735 Pediatrics, Perinatology and Child Health, skin and connective tissue diseases, Hypoxia, Brain, Non-U.S. Gov't, Hypoxia, Spectroscopy, Near-Infrared, business.industry, Research Support, Non-U.S. Gov't, Infant, Newborn, Cerebral hypoxia, Electroencephalography, Hypoxia (medical), medicine.disease, Spectroscopy, near-infrared, 10027 Clinic for Neonatology, Infant newborn, Clinical trial, Metabolism, Multicenter study, Brain Injuries, Pediatrics, Perinatology and Child Health, Cardiology, sense organs, medicine.symptom, business, 030217 neurology & neurosurgery, Biomarkers
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.

Published
2016
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19. Brain injury in the international multicenter randomized SafeBoosC phase II feasibility trial: cranial ultrasound and magnetic resonance imaging assessments

Author

Anne Mette Plomgaard, Cornelia Hagmann, Petra M A Lemmers, Thomas Alderliesten, Gorm Greisen, Monica Fumagalli, Eugene M. Dempsey, Frank van Bel, Simon Hyttel-Sorensen, Adelina Pellicer, Manon J.N.L. Benders, Olivier Claris, Topun Austin, Christian Gluud, Axel R. Franz, Gerhard Pichler, University of Zurich, and Plomgaard, Anne M

Subjects
International Cooperation, Diseases, Infant, Premature, Diseases, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Birth Weight, Non-U.S. Gov't, Hypoxia, Ultrasonography, Observer Variation, medicine.diagnostic_test, Research Support, Non-U.S. Gov't, Gestational age, Cerebral hypoxia, Magnetic Resonance Imaging, Perfusion, Intraventricular hemorrhage, Anesthesia, Cerebrovascular Circulation, medicine.medical_specialty, 610 Medicine & health, Gestational Age, Hemorrhage, Research Support, Cerebral palsy, 03 medical and health sciences, Infant, premature, 030225 pediatrics, medicine, Journal Article, Humans, 2735 Pediatrics, Perinatology and Child Health, Clinical Investigation, Cerebral perfusion pressure, Cerebral Hemorrhage, business.industry, Skull, Infant, Newborn, Magnetic resonance imaging, 10027 Clinic for Neonatology, medicine.disease, Surgery, Oxygen, Brain Injuries, Pediatrics, Perinatology and Child Health, Feasibility Studies, business, 030217 neurology & neurosurgery
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.

Published
2016
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20. Brain injury in the international multicenter randomized SafeBoosC phase II feasibility trial: cranial ultrasound and magnetic resonance imaging assessments.

Author

Plomgaard AM, Hagmann C, Alderliesten T, Austin T, van Bel F, Claris O, Dempsey E, Franz A, Fumagalli M, Gluud C, Greisen G, Hyttel-Sorensen S, Lemmers P, Pellicer A, Pichler G, and Benders M

Subjects
Birth Weight, Brain Injuries pathology, Cerebral Hemorrhage diagnostic imaging, Cerebral Hemorrhage pathology, Cerebrovascular Circulation, Feasibility Studies, Gestational Age, Hemorrhage physiopathology, Humans, Hypoxia physiopathology, Infant, Newborn, Infant, Premature, Diseases pathology, International Cooperation, Observer Variation, Oxygen chemistry, Perfusion, Skull diagnostic imaging, Skull pathology, Brain Injuries diagnostic imaging, Infant, Premature, Diseases diagnostic imaging, Magnetic Resonance Imaging, Ultrasonography
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.

Published
2016
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