Table 3

List of Expected Serious Adverse Events

Serious adverse event

Estimated incidence [17]


Death

20%

Necrotising enterocolitis (diagnostic radiological/surgical changes)

15%

Intracranial abnormality on cranial ultrasound scan

15%

(paraenchymal haemorrhage or focal white matter injury)

Ventilator dependency (28 days) and/or oxygen dependency (36 weeks CGA)

65%

Patent ductus arteriosus medical or surgical management

25%

Retinal surgery for retinopathy of prematurity

5%

Pulmonary haemorrhage

5%

Infection ( positive blood culture with clinical signs)

65%

Persistent derangement of liver function tests (36 wks CGA)

10%

Serious extravasation injury (permanent scarring and/or/joint deformity)

<5%


CGA: corrected gestational age

Morgan et al. BMC Pediatrics 2011 11:53   doi:10.1186/1471-2431-11-53

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