Skip to main content

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 Editionâ„¢; BFABP, brain fatty acid binding protein; BPD, bronchopulmonary dysplasia; BSID-III, Bayley Scales of Infant and Toddler Development, Third Editionâ„¢; cUS, cerebral ultrasound; EEG, electroencephalogram; MRI, magnetic resonance imaging; NEC, necrotizing enterocolitis; NIRS, near-infrared spectroscopy; ROP, retinopathy of prematurity.