Here you find Standard Operating Procedures. There is a PDF-version and a Word-version allowing local additions and adaptations.
The overall purpose of a SOP is to ensure adherence to the protocol.

  • Cerebral oxymetri. NIRS device and sensor handling during SafeBoosC (PDF incl. track changes)
  • Treatment guideline (PDF)
  • aEEG (PDF)
  • Data transfer to Copenhagen Trial Unit (PDF)
  • Cerebral ultrasound (PDF)
  • Collection of blood and urine (PDF incl. track changes)
  • Shipment of samples (PDF)
  • Labels dry ice and biological substance (PDF)
  • Adverse events and reactions (PDF)
  • Sponsor report of adverse events (PDF)
  • Screening (PDF)
  • Randomisation (PDF)
  • Brain MRI (PDF)
  • 2 year follow up with ASQ (PDF)
  • 2-year follow up visit – Bayley and medical examination  (PDF​)​​