Table 3

AEs included in the current version of INC NAESS

AEs in INC neonatal AE severity scale
Neurological Respiratory
Neonatal convulsionInfantile apnoea
Neonatal epileptic seizureNeonatal respiratory insufficiency
Neonatal intraventricular haemorrhage*Neonatal respiratory distress syndrome
Retinopathy of prematurity*Neonatal pulmonary haemorrhage*
Hypoxic ischaemic encephalopathyPersistent pulmonary hypertension of the newborn*
Periventricular leukomalacia*Neonatal pneumothorax*
Infant irritabilityBronchopulmonary dysplasia
Infant sedation* Gastrointestinal
Cardiovascular Necrotising enterocolitis
Neonatal hypotensionNeonatal diarrhoea*
Neonatal hypertension*Infantile vomiting*
Neonatal sinus tachycardia*Feeding intolerance
Neonatal sinus bradycardiaNeonatal gastrointestinal bleeding*
Neonatal tachyarrhythmia*Neonatal spontaneous intestinal perforation*
Neonatal bradycardiaNeonatal constipation*
Neonatal oedema* General
Neonatal coagulation disorder*Neonatal rash*
Infectious Neonatal administration site complication*
Neonatal culture positive sepsis*Neonatal fever*
Neonatal culture negative sepsis* 

  • For these 35 AEs, specific severity criteria were defined.

  • AE, adverse event; INC, International Neonatal Consortium; NAESS, neonatal AE severity scale.