Clinical trial NCT05416918: Clinical Value of Metagenomic Sequencing in Neonatal Sepsis
Official title: Assessing the Clinical Value of Metagenomics Sequencing for the Diagnosis and Treatment of Neonatal Sepsis: a Multicenter Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Sepsis
Keywords: Neonatal Sepsis
Metagenomics
High-Throughput Nucleotide Sequencing
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Quanzhou Women's and Children's Hospital
name: Shengjing Hospital
name: Jiangxi Maternal and Child Health Hospital
name: Northwest Women's and Children's Hospital, Xi'an, Shaanxi
name: Nanjing Maternity and Child Health Care Hospital
name: The First Hospital of Jilin University
name: Hunan Children's Hospital
name: Henan Provincial People's Hospital
name: Tianjin Central Hospital of Gynecology Obstetrics
name: Jiangxi Children's Hospital
name: Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
name: Xinjiang Children's Hospital
name: Shenzhen Maternity and Child Healthcare Hospital
name: Children's Hospital of Nanjing Medical University
name: Gansu Provincial Maternal and Child Health Care Hospital
name: Kunming Children's Hospital
name: Fujian Provincial Maternity and Children
name: Zhuhai Women and Children's Hospital
name: Xiamen Children's Hospital
name: Children's Hospital Affiliated to Shandong University
name: Henan Maternal and Child Health Care Hospital
name: Wuhan Children's Hospital
First posted: 2022-06-14
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study focuses on neonates with primary clinical diagnosis of sepsis.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic performance of metagenomics sequencing
timeFrame: From the date of first samples enrolled until the last samples detected, up to 2 years.
Secondary outcomes:
measure: Clinical impact of metagenomics sequencing
timeFrame: From the date of first samples enrolled until the last samples detected, up to 2 years.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children Hospital of Fudan University
Study officials:
affiliation: Children's Hospital of Fudan University
name: Wenhao Zhou, Doctor
role: STUDY_CHAIR
References: