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O-221 Safeboosc – A Phase Ii Randomised Clinical Trial On Cerebral Near-infrared Spectroscopy Oximetry In Extremely Preterm Infants
  1. S Hyttel-Sorensen1,
  2. A Pellicer2,
  3. T Alderliesten3,
  4. T Austin4,
  5. F van Bel3,
  6. M Benders3,
  7. O Claris5,
  8. E Dempsey6,
  9. AR Franz7,
  10. M Fumagalli8,
  11. C Gluud9,
  12. B Grevstad9,
  13. C Hagmann10,
  14. P Lemmers3,
  15. W van Oeveren11,
  16. G Pichler12,
  17. AM Plomgaard1,
  18. J Riera2,
  19. L Sanchez2,
  20. P Winkel9,
  21. M Wolf13,
  22. G Greisen1
  1. 1Neonatology, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark
  2. 2Neonatology, La Paz University Hospital, Madrid, Spain
  3. 3Neonatology, University Medical Center Utrecht Wilhelmina Children’s Hospita, Utrecht, Netherlands
  4. 4Neonatology, Rosie Hospital Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
  5. 5Neonatology, Hopital Femme Mere Enfants, Lyon, France
  6. 6Neonatology, Cork University Maternity Hospital, Cork, Ireland
  7. 7Neonatology, University Children’s Hospital Tübingen, Tübingen, Germany
  8. 8Neonatology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milano, Italy
  9. 9The Copenhagen Trial Unit Centre for Clinical Intervention Research, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark
  10. 10Neonatology, University Hospital Zurich, Zurich, Switzerland
  11. 11Haemoscan BV, Haemoscan BV, Groningen, Netherlands
  12. 12Neonatology, Medical University Graz, Graz, Austria
  13. 13Biomedical Optics Research Laboratory, University Hospital Zurich, Zurich, Switzerland


Background and aims Extremely preterm infants have a high risk of moderate to severe long-term neurodevelopmental impairment. Hypoxic or hyperoxic brain injury may be a contributing factor. The SafeBoosC trial investigated if it is possible to stabilise the cerebral oxygenation of extremely preterm infants.

Methods This was a phase II randomised, single blinded, clinical trial. Infants born before 28 weeks of gestation were eligible. Within 3 h of birth, infants were randomly assigned to either cerebral near infrared spectroscopy (NIRS) oxygenation monitoring in combination with a treatment guideline (experimental) or blinded NIRS monitoring with standard care (control). The primary outcome was the area under the curve of the time series of absolute deviation from the cerebral oxygenation target range of 55% to 85%, expressed in % hours (the burden of hypoxia and hyperoxia). We hypothesised that there would be more than 50% reduction in this burden in the experimental group.

Results 166 infants with a median postmenstrual age of 26.4 weeks were enrolled (Table 1). Two infants were withdrawn. 86 infants randomised to the NIRS group had a median burden of hypoxia and hyperoxia of 36.1% hours (IQR 9.2 to 79.5) compared with 81.3% hours (IQR 38.5 to 181.3) in the control group (Figure 1), a reduction of 58% (95% CI 35% to 73%) (p= <0.0001). We found no other statistically significant differences between the two groups to term corrected age.

Conclusions Cerebral oxygenation was stabilised using a treatment guideline in combination with cerebral NIRS monitoring in extremely preterm infants.

Abstract O-221 Table 1

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