Clinical Value of Metagenomic Sequencing in Neonatal Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-12-30

Brief Summary

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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

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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.

Conditions

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Neonatal Sepsis

Keywords

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Neonatal Sepsis Metagenomics High-Throughput Nucleotide Sequencing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

0 Days

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wenhao Zhou, Doctor

Role: STUDY_CHAIR

Children's Hospital of Fudan University

Locations

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Children Hospital of Fudan University

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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CHFudanU_NNICU18

Identifier Type: -

Identifier Source: org_study_id

Clinical Value of Metagenomic Sequencing in Neonatal Sepsis

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Quanzhou Women's and Children's Hospital

Shengjing Hospital

Jiangxi Maternal and Child Health Hospital

Northwest Women's and Children's Hospital, Xi'an, Shaanxi

Nanjing Maternity and Child Health Care Hospital

The First Hospital of Jilin University

Hunan Children's Hospital

Henan Provincial People's Hospital

Tianjin Central Hospital of Gynecology Obstetrics

Jiangxi Children's Hospital

Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region

Xinjiang Children's Hospital

Shenzhen Maternity and Child Healthcare Hospital

Children's Hospital of Nanjing Medical University

Gansu Provincial Maternal and Child Health Care Hospital

Kunming Children's Hospital

Fujian Provincial Maternity and Children

Zhuhai Women and Children's Hospital

Xiamen Children's Hospital

Children's Hospital Affiliated to Shandong University

Henan Maternal and Child Health Care Hospital

Wuhan Children's Hospital