Table 1.

Outcome measures of the SafeBoosC phase II 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

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.