Brain injury in the international multicenter randomized SafeBoosC phase II feasibility trial: cranial ultrasound and magnetic resonance imaging assessments
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Brain injury in the international multicenter randomized SafeBoosC phase II feasibility trial : cranial ultrasound and magnetic resonance imaging assessments. / 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.
In: Pediatric Research, Vol. 79, No. 3, 03.2016, p. 466-472.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Brain injury in the international multicenter randomized 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-Sørensen, Simon
AU - Lemmers, Petra
AU - Pellicer, Adelina
AU - Pichler, Gerhard
AU - Benders, Manon
PY - 2016/3
Y1 - 2016/3
N2 - 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.
AB - 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.
U2 - 10.1038/pr.2015.239
DO - 10.1038/pr.2015.239
M3 - Journal article
C2 - 26571218
VL - 79
SP - 466
EP - 472
JO - Pediatric Research
JF - Pediatric Research
SN - 0031-3998
IS - 3
ER -
ID: 161388914