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Pediatr Res. 2016 Mar;79(3):466-72. doi: 10.1038/pr.2015.239. Epub 2015 Nov 16.

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

Author information

1
Department of Neonatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
2
Clinic of Neonatology, University of Zurich, Zurich, Switzerland.
3
University Medical Center Utrecht, Wilhelmina Children's Hospital, Utrecht, The Netherlands.
4
Rosie Maternity Hospital Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
5
Department of Neonatology, Hospital Femme Mere Enfants, Bron, France.
6
Department of Paediatrics and Child Health, University College Cork, Cork, Ireland.
7
Department of Neonatology, University of Tuebingen, Tübingen, Germany.
8
NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
9
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
10
Department of Neonatology, La Paz University Hospital, Madrid, Spain.
11
Department of Pediatrics, Medical University of Graz, Graz, Austria.

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.

PMID:
26571218
PMCID:
PMC4823642
DOI:
10.1038/pr.2015.239
[Indexed for MEDLINE]
Free PMC Article

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