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Table 2 Outcome parameters per analysis

From: 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

  

Intention-to-treat

Per-protocol

Early Rx

(n = )

Expectant

(n = )

Early Rx

(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

    
  1. 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)
  2. 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, Rx pharmacological treatment, SIP spontaneous gastrointestinal perforation