Clinical Value of Metagenomic Sequencing in Neonatal Sepsis

Fudan University

Status: Completed

Conditions: Neonatal Sepsis

Study type: Observational

Funder types: Other

Identifiers

NCT05416918

CHFudanU_NNICU18

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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.