SynthesisPediatric research2023
Neonatal sepsis definitions from randomised clinical trials.
Synthesis in Pediatric research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 65 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
65 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Discontinuation of empirical antibiotics in suspected neonatal early-onset sepsis: a systematic review and meta-analysis.Pediatric research · 2026Pooled it
- Using molecular methods to diagnose, classify, and treat neonatal sepsis: a scoping review.Frontiers in pediatrics · 2025Pooled it
- Management of neonates at risk of early onset sepsis: a probability-based approach and recent literature appraisal : Update of the Swiss national guideline of the Swiss Society of Neonatology and the Pediatric Infectious Disease Group Switzerland.European journal of pediatrics · 2024Guideline
- Impact of neonatal sepsis on neurocognitive outcomes: a systematic review and meta-analysis.BMC pediatrics · 2024Pooled it
- Octenidine or Sterile Water Cleansing and Late-Onset Sepsis in Neonates in the NICU: A Randomized Clinical Trial.JAMA network open · 2026Trial
- Evaluation of umbilical cord blood presepsin in the diagnosis of neonatal early-onset sepsis.Frontiers in pediatrics · 2026Trial
- Preventing Sepsis in Preterm Infants with Bovine Lactoferrin: A Randomized Trial Exploring Immune and Antioxidant Effects.Nutrients · 2025Trial
- Initiation of enteral feeding as per current protocol (at 24 h) versus as per clinical status (from 6 h onwards) in neonates born with antenatal reversed end diastolic flow (REDF) in the umbilical artery Doppler: a pilot randomized controlled trial.Journal of perinatology : official journal of the California Perinatal Association · 2025Trial
- Early-onset neonatal sepsis and neonatal antibiotic exposure in Hungary a nationwide population-based study.European journal of pediatrics · 2026Article
- Machine Learning-Based Prediction of Culture-Confirmed Neonatal Sepsis in a Tertiary Neonatal Intensive Care Unit: Retrospective Cohort Study.JMIR medical informatics · 2026Article
- Heterogeneity of Critical Organ Dysfunction During Late-Onset Bacteremia in Preterm Infants.JAMA network open · 2026Observational
- Interleukin-6 as a sepsis biomarker in neonatal and pediatric care: A retrospective real world cohort study.European journal of pediatrics · 2026Article
- Neonatal sepsis definitions for randomised-controlled trials: challenges and approaches.International journal of epidemiology · 2026Article
- What's in a name? The critical importance of definitions in clinical medicine.Pediatric research · 2026Article
- Machine learning identifies neutrophil-related signatures for diagnostic value in neonatal sepsis.Journal of clinical biochemistry and nutrition · 2026Article
- Evaluation of sequential serum amyloid A measurements for the prediction of sepsis and survival in critically ill neonatal foals.Journal of veterinary internal medicine · 2026Article
- Aligning neonatal sepsis triage diagnostics with WHO target product profiles in low- and middle-income countries.BMJ global health · 2026Review
- On the usage of artificial intelligence for identifying main attributes and predicting neonatal sepsis.Scientific reports · 2026Article
- Early-Onset Neonatal Sepsis: Clinical System Involvement and Maternal-Neonatal Risk Profiles in a Retrospective Cohort Study.Children (Basel, Switzerland) · 2026Article
- Blood cultures to define neonatal early-onset sepsis: why not enough for clinical care?Pediatric research · 2026Article
5 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
- Erratum issued
Authors and funding
35 authors.
Funding
Abstract
introductionNeonatal sepsis is a leading cause of infant mortality worldwide with non-specific and varied presentation. We aimed to catalogue the current definitions of neonatal sepsis in published randomised controlled trials (RCTs).
methodA systematic search of the Embase and Cochrane databases was performed for RCTs which explicitly stated a definition for neonatal sepsis. Definitions were sub-divided into five primary criteria for infection (culture, laboratory findings, clinical signs, radiological evidence and risk factors) and stratified by qualifiers (early/late-onset and likelihood of sepsis).
resultsOf 668 papers screened, 80 RCTs were included and 128 individual definitions identified. The single most common definition was neonatal sepsis defined by blood culture alone (n = 35), followed by culture and clinical signs (n = 29), and then laboratory tests/clinical signs (n = 25). Blood culture featured in 83 definitions, laboratory testing featured in 48 definitions while clinical signs and radiology featured in 80 and 8 definitions, respectively. DISCUSSION: A diverse range of definitions of neonatal sepsis are used and based on microbiological culture, laboratory tests and clinical signs in contrast to adult and paediatric sepsis which use organ dysfunction. An international consensus-based definition of neonatal sepsis could allow meta-analysis and translate results to improve outcomes.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.