Brain injury in the international multicentre randomised 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

doi:10.1038/pr.2015.239

Brain injury in the international multicentre randomised 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

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Abstract

BACKGROUND: Abnormal cerebral perfusion during the first days of life in preterm infants is associated with higher grades of intraventricular haemorrhages 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 MRI, (iii) local and central cUS-assessment.

METHODS: 166 extremely preterm infants were included. cUS was scheduled for day 1,4,7,14,35 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 versus 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.

CONCLUSIONS: 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 72hours of life prevents brain injury, should be evaluated in larger multicentre trials.Pediatric Research (2015); doi:10.1038/pr.2015.239.

Original language	English
Pages (from-to)	466–472
Journal	Pediatric Research
Volume	79
DOIs	https://doi.org/10.1038/pr.2015.239
Publication status	Published - 2016

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Plomgaard, A. M., 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., & Benders, M. (2016). Brain injury in the international multicentre randomised SafeBoosC phase II feasibility trial: cranial ultrasound and magnetic resonance imaging assessments. Pediatric Research, 79, 466–472. https://doi.org/10.1038/pr.2015.239

@article{8388480d90914697b3c73ab6d4d399ca,

title = "Brain injury in the international multicentre randomised SafeBoosC phase II feasibility trial: cranial ultrasound and magnetic resonance imaging assessments",

abstract = "BACKGROUND: Abnormal cerebral perfusion during the first days of life in preterm infants is associated with higher grades of intraventricular haemorrhages 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 MRI, (iii) local and central cUS-assessment.METHODS: 166 extremely preterm infants were included. cUS was scheduled for day 1,4,7,14,35 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 versus 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.CONCLUSIONS: 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 72hours of life prevents brain injury, should be evaluated in larger multicentre trials.Pediatric Research (2015); doi:10.1038/pr.2015.239.",

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

year = "2016",

doi = "10.1038/pr.2015.239",

language = "English",

volume = "79",

pages = "466–472",

journal = "Pediatric Research",

issn = "0031-3998",

publisher = "Lippincott Williams & Wilkins",

}

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 & Benders, M 2016, 'Brain injury in the international multicentre randomised SafeBoosC phase II feasibility trial: cranial ultrasound and magnetic resonance imaging assessments', Pediatric Research, vol. 79, pp. 466–472. https://doi.org/10.1038/pr.2015.239

TY - JOUR

T1 - Brain injury in the international multicentre randomised SafeBoosC phase II feasibility trial

T2 - cranial ultrasound and magnetic resonance imaging assessments

AU - Plomgaard, Anne M

AU - Hagmann, Cornelia

AU - Alderliesten, Thomas

AU - Austin, Topun

AU - van Bel, Frank

AU - Claris, Olivier

AU - Dempsey, Eugene

AU - Franz, Axel

AU - Fumagalli, Monica

AU - Gluud, Christian

AU - Greisen, Gorm

AU - Hyttel-Sorensen, Simon

AU - Lemmers, Petra

AU - Pellicer, Adelina

AU - Pichler, Gerhard

AU - Benders, Manon

PY - 2016

Y1 - 2016

N2 - BACKGROUND: Abnormal cerebral perfusion during the first days of life in preterm infants is associated with higher grades of intraventricular haemorrhages 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 MRI, (iii) local and central cUS-assessment.METHODS: 166 extremely preterm infants were included. cUS was scheduled for day 1,4,7,14,35 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 versus 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.CONCLUSIONS: 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 72hours of life prevents brain injury, should be evaluated in larger multicentre trials.Pediatric Research (2015); doi:10.1038/pr.2015.239.

AB - BACKGROUND: Abnormal cerebral perfusion during the first days of life in preterm infants is associated with higher grades of intraventricular haemorrhages 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 MRI, (iii) local and central cUS-assessment.METHODS: 166 extremely preterm infants were included. cUS was scheduled for day 1,4,7,14,35 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 versus 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.CONCLUSIONS: 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 72hours of life prevents brain injury, should be evaluated in larger multicentre trials.Pediatric Research (2015); doi:10.1038/pr.2015.239.

U2 - 10.1038/pr.2015.239

DO - 10.1038/pr.2015.239

M3 - Article

C2 - 26571218

SN - 0031-3998

VL - 79

SP - 466

EP - 472

JO - Pediatric Research

JF - Pediatric Research

ER -

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

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