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Table 1 Defined quality deficiencies for SafeBoosC-III randomised clinical trial

From: Central data monitoring in the multicentre randomised SafeBoosC-III trial – a pragmatic approach

1.

Proportion of participants without an early and a late cranial ultrasound scan (including only participants alive after 35 days of life)

2.

Late initiation of cerebral oximetry monitoring (0 to 6 h from birth)

3.

Proportion of participants where cerebral oximetry was stopped prematurely (including only participants alive after 72 h of life)

4.

Proportion of participants where consent was withdrawn or declined by the parents

5.

Proportion of participants with a severe brain injury but no cranial ultrasound scan

6.

Proportion of participants with post-haemorrhagic ventricular dilatation or cerebral atrophy but no late cranial ultrasound scan

7.

Proportion of participants in the control group that underwent unblinded cerebral oximetry monitoring