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

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  1. Cerebral oxygenation and blood flow in normal term infants at rest measured by a hybrid near-infrared device (BabyLux)

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  2. Co-occurrence of infantile hypertrophic pyloric stenosis and congenital heart defects: a nationwide cohort study

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  3. Serum, plasma and erythrocyte membrane lipidomes in infants fed formula supplemented with bovine milk fat globule membranes

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  4. Extreme neonatal hyperbilirubinemia, acute bilirubin encephalopathy, and kernicterus spectrum disorder in children with galactosemia

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  5. NKG2D gene variation and susceptibility to viral bronchiolitis in childhood

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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.Pediatric Research (2015); doi:10.1038/pr.2015.266.

Original languageEnglish
JournalPediatric Research
Volume79
Issue number4
Pages (from-to)528-35
ISSN0031-3998
DOIs
Publication statusPublished - 2016

ID: 45946615