Clinical Value of Metagenomic Sequencing in Neonatal Sepsis

NCT05416918 | Completed DMC

• 1 other identifier: CHFudanU_NNICU18
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Sepsis

Keywords

Neonatal Sepsis; Metagenomics; High-Throughput Nucleotide Sequencing

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of metagenomics sequencing

  The diagnostic performance of metagenomics sequencing for neonatal sepsis was evaluated by calculating sensitivity and specificity. Sensitivity = mNGS positive samples/ reference standard methods positive samples; Specificity = mNGS negative samples/ reference standard methods negative samples.

  From the date of first samples enrolled until the last samples detected, up to 2 years.

Secondary Outcomes (1)

• Clinical impact of metagenomics sequencing

  From the date of first samples enrolled until the last samples detected, up to 2 years.

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

This study focuses on neonates with primary clinical diagnosis of sepsis.

You may qualify if:

• Neonates with suspected early-onset sepsis or late-onset sepsis;
• Neonates diagnosed with clinical sepsis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Quanzhou Women's and Children's Hospital: collaborator
• Shengjing Hospital: collaborator
• Jiangxi Maternal and Child Health Hospital: collaborator
• Northwest Women's and Children's Hospital, Xi'an, Shaanxi: collaborator
• Nanjing Maternity and Child Health Care Hospital: collaborator
• The First Hospital of Jilin University: collaborator
• Hunan Children's Hospital: collaborator
• Henan Provincial People's Hospital: collaborator
• Tianjin Central Hospital of Gynecology Obstetrics: collaborator
• Jiangxi Children's Hospital: collaborator
• Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region: collaborator
• Xinjiang Children's Hospital: collaborator
• Shenzhen Maternity and Child Healthcare Hospital: collaborator
• Children's Hospital of Nanjing Medical University: collaborator
• Gansu Provincial Maternal and Child Health Care Hospital: collaborator
• Kunming Children's Hospital: collaborator
• Fujian Provincial Maternity and Children: collaborator
• Zhuhai Women and Children's Hospital: collaborator
• Xiamen Children's Hospital: collaborator
• Children's Hospital Affiliated to Shandong University: collaborator
• Henan Maternal and Child Health Care Hospital: collaborator
• Wuhan Children's Hospital: collaborator

Study Sites (1)

Children Hospital of Fudan University

Shanghai, 201102, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

At the same time of sending conventional blood culture or cerebrospinal fluid culture, 2ml of blood and 1ml of cerebrospinal fluid were collected additionally.

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wenhao Zhou, Doctor

  Children's Hospital of Fudan University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 14, 2022
• Study Start: April 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 30, 2022
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

CN (1)