Table 1.

List of Expected Serious Adverse events

Adverse event	Estimated incidence
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%**

* based on incidence of these complications at Liverpool Women's Hospital

** based on incidences estimated by the investigators