Harm range: Severe temporary harm to death.
Sepsis remains a significant contributor to morbidity and mortality in neonates. Early-onset neonatal sepsis (occurring within the first 72 hours of birth) is generally transmitted from the mother after premature rupture of membranes or amniotic infection (de St. Maurice) or when the baby is delivered at less than 35 weeks gestation. The mortality rate of early-onset sepsis among infants born at term has been declining due to increased awareness. Mortality for late-onset sepsis (between three days and 28 days of birth) has remained unchanged due to the unpredictability of environmental pathogens (Puopolo et al; Singh et al) and difficulty recognizing the condition.
Causes
Contributing factors may include:
- Nonspecific symptoms:
- Neurologic findings (e.g., seizures, reduced movements, reduced sucking)
- Low blood sugar
- Changes in breathing
- Low heart rate
- Gastrointestinal changes (e.g., vomiting, diarrhea, abdominal distention)
- Body temperature changes (but fever is only present in < 10% of neonates (de St. Maurice)
- Varied presentation among neonates and between other pediatric age groups
- Failure to recognize symptomatic changes due to gradual onset
- Failure to report important clinical assessment details in handoff
- Delays in appropriate antibiotic treatment due to prolonged testing for cultures or misidentification of the suspected organism
- Assuming symptoms are related to other causes (e.g., magnesium exposure)
- Invasive devices and prolonged hospitalization
Harm
In recent safety events, failure to recognize neonatal sepsis resulted in organ failure and death. More significant harm events were common for premature infants due to a deficient immune system, an immature skin barrier, and an increased need for invasive devices such as central lines, feeding tubes, and urinary catheters (Singh et al.).
Recommendations
- Create evidence-based clinical care pathways that include recommendations for screening, diagnosis, treatment, and follow-up care.
- Ensure all care providers are aware of the organization’s clinical pathways, screening tools, and resources available for neonatal sepsis.
- Utilize multivariate algorithms that assess risk based on intrapartum factors and neonatal assessment (e.g., Neonatal Early-Onset Sepsis Calculator).
- Build sepsis triggers into the electronic medical record based on the patient’s age. Consider simultaneous prompts for a Diagnostic Timeout (see Resources).
- Include differential diagnoses in provider and nursing handoff templates to counter anchoring bias.
- Ensure aseptic care of the environment and invasive devices.
- Lower the admission threshold for ill-appearing infants with vague symptoms, especially when seen multiple times in a short timeframe.
- Ensure the presence of pediatric-trained providers in the emergency department.
- Create an organizational culture that allows members to comfortably escalate concerns, even for minor clinical changes.
Resources
- Improving Pediatric Sepsis Outcomes Change Package
- Diagnostic Safety Toolkit
- Improving Communication in the Diagnostic Process Action Alert
- Neonatal Early-Onset Sepsis Calculator
- Pediatric Learning Solutions (PLS) Training Module: Neonatal Sepsis (CE 1.0)
References
De St. Maurice, A. (2025). Neonatal Sepsis. Merck Manual.
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