Table 1

Characteristics of the outcome measures

OutcomeMeasurement of variable (units)Statistical estimates and measurement of association
  • Primary

Failure to close the PDAFailure to closure of the PDA. We will emphasise on closure definition within a week of administration of the first dose of the intervention (PDA diagnosed either clinically or by ECHO criteria), but we will use the time defined by authors to analyse the outcome accordingly.OR (95% CrI)
  • Secondary

  • General outcomes

–Neonatal mortalityDeath during the first 28 days of life.OR (95% CrI)
–Reopening of the ductus arteriosusNumber of neonates with echocardiographic determination of reopening of the ductus.
–Need for surgical closure of the PDANumber of neonates who required surgical treatment of the PDA.
–CLDTotal number of neonates with oxygen requirement at 28 days postnatal age in addition to compatible clinical and roentgenographic findings.
  • Neurological effects

  • –IVH

  • Number of neonates with IVH (I–IV).

OR (95% CrI)
  • –Severe IVH

  • Number of neonates with severe IVH.

  • –PVL

  • Number of neonates with PVL.

  • –Neurodevelopmental disability

  • Number of children with any reported disability at 1–2 years of age (eg, motor, cognitive, sensory impairments).

Gastrointestinal and nutritional effects
  • Intestinal perforation

  • GB

  • NEC

  • Time to full enteral feeds

  • Number of neonates with Intestinal perforation.

  • Number of neonates with GB.

  • Number of neonates with NEC (any stage).

  • Postnatal age at time of achieving full enteral feeds.

  • OR (95% CrI)

  • OR (95% CrI)

  • MD (95% CrI)

  • OR (95% CrI)

  • Renal effects

– Decreased urine outputNumber of neonates with urine output, defined as <1 cc/kg/hour.
  • OR (95% CrI)

  • CLD, chronic lung disease; ECHO, echocardiographically; GB, gastrointestinal bleed; IVH, intraventricular haemorrhage; MD, mean difference; NEC, necrotising enterocolitis; PDA, patent ductus arteriosus; PVL, periventricular leukomalacia.