Neonatal sepsis definitions from randomised clinical trials

Area of Science:

• Neonatal Medicine
• Infectious Diseases
• Clinical Trial Methodology

Background:

• Neonatal sepsis is a primary driver of infant mortality globally, characterized by nonspecific and diverse clinical presentations.
• Current research lacks a unified definition for neonatal sepsis, hindering consistent diagnosis and treatment across studies.

Approach:

• A systematic literature review was conducted across Embase and Cochrane databases to identify randomized controlled trials (RCTs) explicitly defining neonatal sepsis.
• Identified definitions were categorized based on primary criteria (culture, lab tests, clinical signs, radiology, risk factors) and qualifiers (onset, likelihood).

Key Points:

• Out of 668 screened papers, 80 RCTs were included, yielding 128 distinct definitions of neonatal sepsis.
• The most frequent definitions involved blood culture alone (35 studies), followed by culture plus clinical signs (29 studies), and lab tests/clinical signs (25 studies).
• Blood culture was present in 83 definitions, laboratory tests in 48, clinical signs in 80, and radiology in only 8 definitions.

Conclusions:

• Significant heterogeneity exists in the definitions of neonatal sepsis used in RCTs, primarily based on microbiological, laboratory, and clinical indicators.
• Unlike adult and pediatric sepsis definitions that incorporate organ dysfunction, neonatal sepsis definitions lack this component.
• Establishing an international consensus-based definition for neonatal sepsis is crucial for enabling robust meta-analyses and improving patient outcomes.