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 2 Outcome parameters per analysis

		Intention-to-treat		Per-protocol
		Early R_x (n = )	Expectant (n = )	Early R_x (n = )	Expectant (n = )
*Primary composite outcome*
	Mortality, BPD and/or NEC at 36 weeks PMA
*Secondary outcomes*
Treatment	Total doses of COXi
	Surgical PDA ligation
	Total fluid intake DOL 7 [ml/kg/day]
	Co-interventions
	Postnatal steroids
	Paracetamol use
	Diuretics
Death	Mortality at 28 days PNA
	Mortality at 36 weeks PMA
	Mortality
Haemodynamic	Cardiovascular support
	Volume expansion
	Inotropes/vasopressors
	Corticosteroids
	Hyperlactataemia
	Renal failure
	Hypertension
Pulmonary	BPD at 28 days PNA
	BPD at 36 weeks PMA
	Supplemental oxygen [days]
	Respiratory support [days]
	Invasive
	Non-invasive
	Pulmonary haemorrhage
	Pulmonary air leakage
CNS	PVE
	IVH
	Grade I-II
	Grade ≥ III
	PHVD
	Seizures
GI	NEC (Bell stage ≥ IIa)
	Gastrointestinal haemorrhage
	SIP
	Time to full enteral feeding [days]
Infection	Sepsis
	Meningitis
	Pneumonia
	Thrombocytopenia
	Hyperglycaemia
Eye	ROP
	PLUS disease
	ROP treatment
Miscellaneous	Biometry at PMA 36 weeks
	Weigth [grams]
	Length [cm]
	Biometry at discharge
	Weigth [grams]
	Length [cm]
	Length of hospitalisation [days]
	DA closed at discharge

All outcome measures are till hospital discharge to home unless otherwise specified. Data is presented as mean (± standard deviation) or median [interquartile ranges]. Categorical variables are presented as counts (percentage)
BPD bronchopulmonary dysplasia, CNS central nervous system, COXi cyclo-oxygenase inhibitor, DA ductus arteriosus, DOL day of life, GI gastrointestinal, IVH intraventricular haemorrhage, LF low-flow, MV mechanical ventilation, NEC necrotizing enterocolitis, PDA patent ductus arteriosus, PHVD posthemorrhagic ventricular dilatation, PMA postmenstrual age, PNA postnatal age, PVE periventricular echogenicity, ROP retinopathy of prematurity, R_x pharmacological treatment, SIP spontaneous gastrointestinal perforation

ISSN: 1745-6215