Table 3

Secondary outcomes of infants with a large patent ductus arteriosus (PDA) randomised to indomethacin or placebo

IndomethacinPlacebop Value
N4448
All pulmonary haemorrhage*4 (9%)11 (23%)0.07
Pulmonary haemorrhage during first 72 h*1 (2%)10 (21%)0.004
Gastrointestinal perforation or bleeding*0 (0%)0 (0%)1.0
Necrotising enterocolitis*2 (4.5%)2 (4%)0.49
Creatinine >150 µmol/L*1 (2%)1 (2%)1.0
Time to full feeds (days)†21 (13–27)16 (11–23)0.4
Postnatal steroids*7 (16%)4 (8%)0.34
Inotropes*10 (23%)10 (21%)1.0
Sepsis*14 (32%)18 (38%)0.57
Retinopathy of prematurity treated with laser*0 (0%)3 (6%)0.24
Oxygen/respiratory support at 36 weeks (BPD)*11 (25%)15 (31%)0.29
Open-label treatment PDA*9 (20%)19 (40%)0.04
Open-label treatment age (days)†13 (8–18)5 (2–6)0.003
Surgical ligation PDA*02 (4%)0.5
  • *Number (%).

  • †Median (IQR).

  • BPD, bronchopulmonary dysplasia.