Table 1

Primary composite outcome

Components of composite primary end pointRate (%)Association with long-term adverse outcome
Intrapartum stillbirth700.1*
28-day neonatal mortality0.24
Apgar score <4 at 5 min0.5↑ Risk of cerebral palsy71
Umbilical cord artery pH <7.02.2†↑ Risk of Hypoxic Ischaemic Encephalopathy (HIE)72
Neonatal encephalopathy
Sarnat grade 2 or 373
0.5↑ Risk of death or disability74
Neonatal seizures‡730.25↑ Risk of death or disability74
Neonatal respiratory support for >4 hours3.6↑ Risk of cerebral palsy75
Neonatal unit admission for >48 hours4.3↑ Asthma after term respiratory morbidity76
Persistent pulmonary hypertension730.04↑ Risk of death or disability77
Meconium aspiration730.75↑ Risk of death or disability78
Total (corrected for overlap)7.0
  • *Based on data from Grobman et al.20

  • †Based on data from Yeh et al.72

  • ‡Although seizures include non-encephalopathic causes like stroke or metabolic disorders, in a randomised trial, those causes not influenced by sildenafil will tend to be evenly balanced between study arms and therefore tend not to bias the comparison. In this pragmatic trial, seizures, persistent pulmonary hypertension and meconium aspiration are all defined using local protocols.