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Supplemental Digital Content 1. Neonatal sepsis endpoint definitions 10
Early-onset sepsis: Either early-onset culture-confirmed sepsis or clinical sepsis, as defined
below.
Culture confirmed episodes of sepsis which did not fulfill the clinical sepsis criteria were
reviewed by a panel of three neonatologists to decide if the case represented a sepsis episode.
The records of all stillborn-infants and neonates dying within 2 hours of birth were also reviewed
by this panel to determine whether the cause of death could be attributed to neonatal sepsis. Data
reviewed from maternal and infant medical records included documentation of signs of foetal
distress (meconium stained liquor, decreased variability or severe, prolonged decelerations of
foetal heart rate recorded by cardiotocography), complications in labour (prolonged labour/ poor
progress in labour, foetal malpresentation, maternal death) and signs of neonatal asphyxia (poor
Apgar scores, arterial blood gas results).
Early-onset culture confirmed sepsis: isolation of a micro-organism that is not a common
contaminant from a normally sterile body site within days 0-2 of days of life
Early-onset clinical sepsis: A neonate hospitalised on days 0-2 of life and who in the absence of
another recognizable congenital infection had at least one laboratory criteria and either:
respiratory distress (one criterion required) or at least two clinical criteria (see below).
Late-onset sepsis: Either culture-confirmed sepsis or clinical sepsis in an infant with symptom
onset between day three and 28 of life.
Late-onset culture confirmed sepsis: isolation of a micro-organism that is not a common
contaminant from a normally sterile body site between day three and 28 of life.
Late-onset clinical sepsis: A neonate hospitalised between day three and 28 of life with at least
one laboratory criteria and either: respiratory distress (two criteria required), OR one feature of
respiratory distress and one other clinical criterion OR at least two other clinical criteria.
Table: Neonatal sepsis criteria
Clinical criteria
Definition
Respiratory distress
Respiratory rate >60 breaths/min; cyanosis, chest wall indrawing,
grunting on expiration, or respiratory distress noted in medical
records
Hypotension
defined as mean arterial pressure < 2 standard deviations (S.D.)
from mean for weight/age
pyrexia or hypothermia
axillary temperature >38·0C, not attributable to external
Schrag et al.: Risk factors for neonatal sepsis and death in Soweto
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warming, or axillary temperature <36·0C
Abdominal/ feeding problems
Bleeding diathesis
abdominal distension OR feeding intolerance (>20% residual
over 24 hours), or poor feeding after feeding well, or > 2 episodes
of emesis
defined as petechiae, ecchymosis, mucous membrane bleeding,
pulmonary hemorrhage, or excessive oozing from venipuncture
sites
Lethargy or irritability
noted by medical staff in absence of other central nervous system
symptoms
Central nervous system
seizures, or bulging fontanelle, or single witnessed episode of
apnea
Laboratory criteria
White blood cell count (WCC)
WCC <5 x109/l OR >25 x109/l in the absence of receiving
corticosteroids;
Absolute neutrophil count (ANC)
ANC <1·75 x109/l or >15 x109/l
Platelet count
<150 x109/l
C-reactive protein
> 10·0 mg/l (early onset sepsis) OR >40mg/l (late-onset sepsis)
Elevated CSF white blood cell
(WBC) count
>30 x106/l WBC in absence of significant red blood cells