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) | Â |
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% |