Table 1 List of Expected Serious Adverse events

a) death

20%*

b) necrotising enterocolitis or focal intestinal perforation diagnosed on clinical grounds, or at surgery

15%*

c) intracranial abnormality (parenchymal haemorrhage or focal white matter damage) on cranial ultrasound

15%*

d) requirement for supplementary oxygen 28 days after birth

55%*

e) patent ductus arteriosus requiring medical or surgical management

25%*

f) retinal surgery for retinopathy of prematurity

5%*

g) sustained tachycardia (greater than 220 beats per minute for more than 30 minutes in a 60 minute period)

20%**

h) pulmonary haemorrhage

5%**

i) persistent weight loss after 14 days after birth in the absence of infection.

10%**