Salaets et al reported an adverse event severity scale suitable for use in neonates. The authors are from multiple institutions and the International Neonatal Consortium.
The Common Terminology Criteria for Adverse Events (CTC AE) is used in older patients but may be unsuitable for neonates.
|
Symptoms
|
Change in Baseline Care or Monitoring
|
Change in Age-Appropriate Behavior
|
|
mild or asymptomatic; clinical or diagnostic observations only
|
none
|
none
|
|
moderate
|
minor changes
|
minor changes
|
|
severe
|
major changes due to changes in basal physiological processes
|
major
|
|
life-threatening
|
urgent and major
|
NA
|
|
death
|
NA
|
NA
|
Minor care changes may include brief, local, non-invasive or symptomatic treatments.
Major care changes may include surgery, use of long-term treatment or upscaling care level.
|
Clinical Severity
|
Grade
|
|
mild
|
1
|
|
moderate
|
2
|
|
severe
|
3
|
|
life-threatening
|
4
|
|
death
|
5
|
Conditions with NAESS criteria:
(1) convulsions
(2) epileptic seizures
(3) intraventricular hemorrhage
(4) retinopathy of prematurity
(5) periventricular leukomalacia
(6) irritability
(7) hypotension
(8) hypertension
(9) sinus tachycardia or bradycardia
(10) tachyarrhytmia
(11) edema
(12) neonatal-onset sepsis
(13) apnea
(14) respiratory insufficiency
(15) respiratory distress syndrome
(16) pulmonary hemorrhage
(17) pulmonary hypertension
(18) pneumothorax
(19) bronchopulmonary dysplasia
(20) necrotising enterocolitis
(21) diarrhea
(22) vomiting
(23) feeding intolerance
(24) gastrointestinal bleeding
(25) spontaneous intestinal perforation
(26) constipation
(27) generalized rash
(28) administration site complication
(29) fever
