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1142 Safeguarding the Brains of Our Smallest Children: Safeboosc – the Pilot Study
  1. S Hyttel-Sørensen1,
  2. T Austin2,
  3. M Benders3,
  4. O Claris4,
  5. G Dempsey5,
  6. M Fumagalli6,
  7. C Gluud7,
  8. C Hagmann8,
  9. L Hellström-Westas9,
  10. P Lemmers3,
  11. G Naulaers10,
  12. A Pellicer11,
  13. G Pichler12,
  14. L Saem Støy7,
  15. F van Bel3,
  16. W van Oeveren13,
  17. M Wolf14,
  18. G Greisen15
  1. 1Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
  2. 2Rosie Maternity Hospital, Department of Paediatrics, Cambridge, UK
  3. 3Wilhelmina Children’s Hospital, Department of Neonatology, Utrecht, The Netherlands
  4. 4Hospices Civils de Lyon, Department of Neonatology, Lyon, France
  5. 5University College Cork, Department of Neonatology, Cork, Ireland
  6. 6Università di Milano, Department of Maternal and Pediatric Sciences, Milan, Italy
  7. 7Copenhagen Trial Unit, Rigshospitalet, Copenhagen, Denmark
  8. 8University Hospital Zurich, Clinic of Neonatology, Zurich, Switzerland
  9. 9University Hospital Uppsala, Department of Neonatology, Uppsala, Sweden
  10. 10Katholieke Universiteit Leuven, Department of Neonatology, Leuven, Belgium
  11. 11La Paz University Hospital, Department of Neonatology, Madrid, Spain
  12. 12Medical University of Graz, Department of Paediatrics, Graz, Austria
  13. 13Haemoscan B.V., Groningen, The Netherlands
  14. 14University Hospital Zurich, Biomedical Optics Research Laboratory, Zurich, Switzerland
  15. 15Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark


Background and Aims The SafeBoosC project aims to test the benefits and harms of cerebral near-infrared spectroscopy (NIRS) oximetry in infants born before 28 weeks of gestation. A phase II trial will randomise infants to cerebral NIRS oximetry and a treatment guideline during the first 72 hours of life or standard care with blinded NIRS-monitoring. The primary outcome is the area (burden) outside the normal ranges of rStO2 of 55 to 85%.

Methods This pilot of the experimental group included 10 infants using the INVOS 5100C and NONIN EQUANOX 7600.

Results Median gestational age was 26 weeks + 3 days. Median start-up time was 133 minutes after delivery. Median recording time was 69.7 hours. Mean rStO2 was 64.2 +/- 4.5%. Median burden of hyper- and hypoxia was 30.3% hours (range 2.8–112.3). Clinical staff responded to out of range values 29 times – once was it to a value above 85%. In comparison, there was 83 periods of more than 10 minutes with rStO2 below 55% and four episodes with rStO2 above 85%. These periods accounted for 72% of the total burden of hypoxia. 18/29 of interventions were adjustments of FiO2 that 13 of 18 times resulted in an out of range SpO2. Two infants suffered burns.

Conclusions Early cerebral NIRS monitoring proved feasible, but prolonged periods of hypoxia went untreated, while adjustment of FiO2 often would result in SpO2 out of local target range. This points to a less than perfect implementation of the treatment guideline.

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