Neonatal SepsisNCT05416918
Clinical Value of Metagenomic Sequencing in Neonatal Sepsis
An observational study of Neonatal Sepsis, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Neonatal Sepsis
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: This study focuses on neonates with primary clinical diagnosis of sepsis.
Who may be able to join
- Neonates with suspected early-onset sepsis or late-onset sepsis;
- Neonates diagnosed with clinical sepsis.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Clinical Value of Metagenomics Sequencing for the Diagnosis and Treatment of Neonatal Sepsis: a Multicenter Prospective Observational Study
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.
Read the 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.
- Conditions
- Neonatal Sepsis
- Keywords
- Neonatal Sepsis, Metagenomics, High-Throughput Nucleotide Sequencing
- Medical subject headings
- Neonatal Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the date of first samples enrolled until the last samples detected, up to 2 years.
Secondary outcomes (1)
Clinical impact of metagenomics sequencing
Clinical impact of metagenomics sequencing was evaluated by calculating the positive impact rate, negative impact rate and no impact rate. Positive impact rate = positive impact cases/ total cases; negative impact rate = negative impact cases/ total cases; no impact rate = no impact cases/ total cases. Clinical impact was assessed according to predefined objective grading criteria.
Measured: From the date of first samples enrolled until the last samples detected, up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Apr 2022
- Primary completion1 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal SepsisStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- QuanZhou Women 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 Province Children's Hospital, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Xinjiang Children's Hospital, Shenzhen Maternity & Child Healthcare Hospital, Children's Hospital of Nanjing Medical University, Gansu Provincial Maternal and Child Health Care Hospital, Kunming Children's Hospital, Fujian Maternity and Child Health Hospital, Zhuhai Women and Children's Hospital, Xiamen Children's Hospital, Children's Hospital Affiliated to Shandong University, Henan Provincial Maternal and Child Health Care Hospital, Wuhan Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Wenhao Zhou, Doctor, Study chair, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416918
- Sponsor's protocol ID
- CHFudanU_NNICU18
- Status last verified
- Dec 2023
- First submitted
- 2 Jun 2022
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Clinical Value of Metagenomics Sequencing for the Diagnosis and Treatment of Neonatal Sepsis: a Multicenter Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05416918
- Acronym / sponsor ID
- CHFudanU_NNICU18
- Conditions
- Neonatal Sepsis
- Keywords
- Neonatal Sepsis, Metagenomics, High-Throughput Nucleotide Sequencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- QuanZhou Women 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 Province Children's Hospital, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Xinjiang Children's Hospital, Shenzhen Maternity & Child Healthcare Hospital, Children's Hospital of Nanjing Medical University, Gansu Provincial Maternal and Child Health Care Hospital, Kunming Children's Hospital, Fujian Maternity and Child Health Hospital, Zhuhai Women and Children's Hospital, Xiamen Children's Hospital, Children's Hospital Affiliated to Shandong University, Henan Provincial Maternal and Child Health Care Hospital, Wuhan Children's Hospital
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study focuses on neonates with primary clinical diagnosis of sepsis.
Key inclusion criteria (2 listed)
- Neonates with suspected early-onset sepsis or late-onset sepsis;
- Neonates diagnosed with clinical sepsis.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance of metagenomics sequencing
Time frame: From the date of first samples enrolled until the last samples detected, up to 2 years.
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.
1 secondary outcome
Clinical impact of metagenomics sequencing
Time frame: From the date of first samples enrolled until the last samples detected, up to 2 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenhao Zhou, Doctor study chair
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Sepsis, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of metagenomics sequencing (time frame: From the date of first samples enrolled until the last samples detected, up to 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.