Clinical Value of Metagenomic Sequencing in Neonatal Sepsis

  • End date
    Apr 30, 2025
  • participants needed
  • sponsor
    Children's Hospital of Fudan University
Updated on 3 July 2022


This study aimed to enroll 2000 neonatal patients with suspected sepsis or clinical diagnosed sepsis. These patients will undergo both conventional methods and metagenomics sequencing to detect the pathogenic microorganisms of sepsis. The purpose of this study was to assess the clinical value of metagenomics sequencing for the diagnosis and treatment of neonatal sepsis.


Infectious diseases remain leading causes of mortality and morbidity in children. Rapid and accurate diagnosis of infectious diseases in children is important for developing an effective treatment and management strategy. However, the current diagnosis of infectious agents mainly depends on culture and molecular testing. Both of the methods either has long turnaround times or narrow detection range. Metagenome next generation sequencing (mNGS) has been applied to the diagnosis of central nervous system infection, lower respiratory tract infection and sepsis, which showed high positive rate, short turnaround time. As a multi-center prospective observational clinical study, the study intends to enroll 2000 suspected neonatal sepsis cases from multiple centers. Culture, classical PCR and mNGS were performed simultaneously. This study is one of the few multi-center studies in China to evaluate the value of mNGS in the diagnosis and treatment of neonatal sepsis, and will provide representative data for the distribution characteristics of pathogen spectrum of children in the real world and the clinical diagnosis and treatment value of mNGS.

Condition Neonatal Sepsis
Clinical Study IdentifierNCT05416918
SponsorChildren's Hospital of Fudan University
Last Modified on3 July 2022


Yes No Not Sure

Inclusion Criteria

Neonates with suspected early-onset sepsis or late-onset sepsis
Neonates diagnosed with clinical sepsis

Exclusion Criteria

Died before the results of conventional methods test or metagenomics test were obtained
Suffering from diseases of the blood system
Suffering from malignant tumor
Birth defects, congenital heart disease or autoimmune disease
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