Detailed statistical analysis plan for the SafeBoosC III trial: a multinational randomised clinical trial assessing treatment guided by cerebral oxygenation monitoring versus treatment as usual in extremely preterm infants

Table 1 Overview of power calculations for exploratory outcomes

Outcome	Assumption on prevalence in background population (%)	Assumption on risk increase or decrease (%)	Power (%)
Major neonatal morbidities	0.62 (0.8)^a	20	87
Bronchopulmonary dysplasia	40	20	89
Retinopathy of prematurity	13	30	68
Late-onset sepsis	40	20	91.2
Necrotising enterocolitis	11	17	23

For definition of outcomes, see ‘Outcomes’. All power calculations have been made with a 5% significance level
^aPresented as mean count (standard deviation)

ISSN: 1745-6215