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 |