Multi-centre, randomised non-inferiority trial of early treatment versus expectant management of patent ductus arteriosus in preterm infants (the BeNeDuctus trial): statistical analysis plan

Table 1 Baseline maternal and patient characteristics of randomised patients

		Early pharmacological treatment (n= )	Expectant management (n= )
Maternal characteristics	Maternal age [years]
	Maternal obstetrical disease
	Pre-eclampsia
	HELLP syndrome
	Placental abruption
	PPROM
	Clinical chorioamnionitis
	Maternal medication
	NSAIDs
	Magnesium sulphate
	Tocolysis
	Administration of ACS
	ACS course completed
	Type of delivery
	Vaginal
	Caesarean section
	Multiple birth
Patient characteristics	Gestational age [weeks]
	Birth weight [grams]
	Outborn (yes)
	Gender (male)
	Apgar score at 5 minutes
	Resuscitation after birth
	Non-invasive respiratory support
	Invasive respiratory support
	Circulatory support
	Respiratory distress syndrome
	Surfactant administration
	PDA diameter [mm]

Data is presented as mean (± standard deviation) or median [interquartile ranges]. Categorical variables are presented as counts (percentage)
ACS antenatal corticosteroids, HELLP haemolysis, elevated liver enzymes and low platelets, PDA patent ductus arteriosus, PPROM preterm premature rupture of membranes, NSAIDs non-steroidal anti-inflammatory drugs, TTN transient tachypnea of the newborn

ISSN: 1745-6215