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Updated: Jun 27, 2025

A Neonatal Imaging Model of Gram-Negative Bacterial Sepsis
Published on: August 12, 2020
Diagnostic capacity of miRNAs in neonatal sepsis: a systematic review and meta-analysis
Yihong Zhao1,2, Ruqin Zhu3, Xiaoyan Hu1
1Pediatrics Department, Peking University Shenzhen Hospital, Shenzhen, China.
Background:
Neonatal sepsis is the third leading cause of mortality during the neonatal period, with manifestations atypical and obscure. But the gold standard-blood culture test, requiring 3-5 days, makes it difficult to unveil the final pathogen and leads to the increasing ratio of false-negative results. The empirical method is consulting traditional biomarkers, such as procalcitonin (PCT), C-reactive protein (CRP), and white blood cell count. However, they are not specific for neonate in diagnostic capacity, especially for infants within three days after delivery, so more novel biomarkers are urgently needed to assist diagnosing neonatal sepsis. microRNAs (miRNAs) have been widely studied in recent years for their diagnostic and prognostic values in different diseases and we conducted a meta-analysis of miRNAs on the topic that whether they are potentially novel biomarkers in early detection of neonatal sepsis.
Objectives:
The purpose of the study was to assess whether circulating miRNAs could be used as potential biomarkers for neonatal sepsis, including early and late-onset neonatal sepsis, then calculate their overall accuracy (OA) via meta-analysis.
Methods:
PubMed, Cochrane Library, Embase, Web of Science, Scopus, and Ovid databases were retrieved; data cutoff for this analysis was 15 January 2023. Methodological quality assessment of included studies was performed through the Quality in Prognostic Studies tool. Corresponding 95% confidence interval (95%CI) was calculated to present miRNAs' diagnostic value including the pooled sensitivity (Sen), specificity (Spe), positive or negative likelihood ratios (PLR or NLR), diagnostic odds ratio (DOR), and area under the curve (AUC). Differences in OA between the septic group and non-septic group were compared using Chi-square test.
Results:
After identification, 16 records out of 11 selected articles were eligible for systematic review of miRNAs and four records for PCT; the case group for miRNAs included 945 neonatal sepsis cases; contrast group included 190 respiratory tract infections or pneumonia cases, 60 systemic inflammatory response syndrome (SIRS) cases and 559 healthy neonates. The pooled Sen, Spe, and DOR of miRNAs were 0.87 (95%CI 0.81-0.91), 0.79 (95%CI 0.71-0.85), and 24 (95%CI 12-50), respectively. The pooled Sen, Spe, and DOR of PCT were 0.92 (95%CI 0.83-0.96), 0.64 (95%CI 0.56-0.70), and 20 (95%CI, 7-56), respectively. The OA value of miRNAs was 80.38% and that of PCT was 77.36%, which were not statistically significant difference (p = .13) after the Chi-square test. In addition, no significant publication bias was indicated (p = .92).
Conclusions:
Circulating miRNA levels could be applied as diagnostic biomarkers in neonatal sepsis.
Insights
MicroRNAs show promise as novel biomarkers for early neonatal sepsis detection, offering comparable accuracy to traditional markers like procalcitonin (PCT). This meta-analysis supports their use in improving diagnostic speed and accuracy for this critical condition.
Area of Science:
- Biomarkers and Diagnostics
- Neonatal Medicine
- Molecular Biology
Background:
- Neonatal sepsis is a leading cause of mortality with atypical presentations.
- Current diagnostic methods like blood cultures are slow and have high false-negative rates.
- Existing biomarkers (PCT, CRP) lack specificity in neonates, necessitating novel diagnostic tools.
Purpose of the Study:
- To evaluate circulating microRNAs (miRNAs) as potential biomarkers for neonatal sepsis.
- To assess the diagnostic accuracy of miRNAs for both early and late-onset neonatal sepsis.
- To perform a meta-analysis to determine the overall accuracy (OA) of miRNAs.
Main Methods:
- Systematic review and meta-analysis of studies on miRNAs and neonatal sepsis.
- Searched PubMed, Cochrane Library, Embase, Web of Science, Scopus, and Ovid databases.
- Assessed study quality using the Quality in Prognostic Studies tool and calculated pooled diagnostic values (sensitivity, specificity, DOR, AUC).
Main Results:
- 16 records on miRNAs and 4 on PCT were included, involving 945 sepsis cases.
- Pooled sensitivity, specificity, and DOR for miRNAs were 0.87, 0.79, and 24, respectively.
- Overall accuracy for miRNAs (80.38%) was comparable to PCT (77.36%), with no statistically significant difference.
Conclusions:
- Circulating miRNA levels demonstrate potential as diagnostic biomarkers for neonatal sepsis.
- miRNAs offer a promising avenue for improving early detection and diagnosis of neonatal sepsis.

