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Table 1 Outcome measures of the SafeBoosC phase II trial

From: A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled trial

Tools Outcomes Time points
Primary outcome
Cerebral NIRS oximeter • Burden of hypoxia and hyperoxia • During the intervention until 72 hours after birth
Secondary outcomes
aEEG/EEG • Interburst interval (IBI) • 64 hours after birth
cUS • Worst Brain injury score (1 to 3) of five cUSs • At 1 to 4 days after birth
• At 7 days after birth
• At 14 days after birth
• At 35 days after birth
• At term date
Medical records • All-cause mortality Term date
Exploratory outcomes
Medical records • Serious adverse reactions • During the first 7 days of life
• Non-serious adverse reactions
Cerebral NIRS oximeter • Burden of hypoxia • During the intervention until 72 hours after birth
• Burden of hyperoxia
Blood samples • BFABP • 6 hours after birth
• Neuroketal • 64 hours birth
• S100β
Medical records • Neonatal morbidities: • Term date
• NEC stage 2 to 3
• ROP stage 3+ and above
Medical records Neonatal morbidities: • At 36 weeks
• BPD
aEEG/EEG • Power in delta band • 64 hours after birth
• Power in theta band
• Power in alpha band
• Power in beta band
MRI • Brain injury score (Woodward) • At term date
• Volumetric
• Cortical folding diffusion tensor imaging
BSID-III • Cognitive score • 24 months after term date
• Verbal score
• Motor score
ASQ-III • Total score • 24 months after term date
  1. aEEG, amplitude-integrated electroencephalogram; ASQ-III, Ages and Stages Questionnaires, Third Edition™; BFABP, brain fatty acid binding protein; BPD, bronchopulmonary dysplasia; BSID-III, Bayley Scales of Infant and Toddler Development, Third Edition™; cUS, cerebral ultrasound; EEG, electroencephalogram; MRI, magnetic resonance imaging; NEC, necrotizing enterocolitis; NIRS, near-infrared spectroscopy; ROP, retinopathy of prematurity.