- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06034639
AI Based Multi-modal Parameter of Peripheral Blood Cells (MMPBC) Predicts Survival Risk in Critically Ill Children
AI Based Multi-modal Parameter of Peripheral Blood Cells (MMPBC) Predicts Survival Risk in Critically Ill Children: a Multicenter, Retrospective Cohort Study
Study Overview
Status
Conditions
Detailed Description
According to the definition of the United Nations Children's Fund (UNICEF), children are individuals between the ages of 0 and 18. Critically ill children are those who are admitted to the PICU or NICU and suffer from severe illnesses that require special treatment. These illnesses may endanger the child's life. Studies have reported that the international PICU mortality rate in developed countries is 2% to 3%; in recent years, the in-hospital mortality rate of PICU in China is 4.7% to 6.8%. The assessment of the survival risk of critically ill children has always been a focus of attention. Traditional assessment methods include physiological indicators, scoring tools, severity of illness, and diagnosis time, which can help doctors make decisions to a certain extent, but their predictive ability is limited and difficult to comprehensively reflect the child's physiological status and disease progression.
With the development of technology and social progress, blood cell analysis is evolving towards a highly integrated platform of multiple cell analysis technologies that provide more accurate results, more comprehensive parameters, and faster detection. Cell analysis applications are increasingly focused on the identification and alarm capabilities of abnormal samples, including reticulocytes, nucleated red blood cells, and immature granulocytes. In 2009, Mindray Group, in collaboration with the National Key Laboratory of Fine Chemicals, developed a new nucleic acid-targeted fluorescent dye that meets the requirements of blood cell analysis (the patented fluorescent dye won the National Science and Technology Progress Second Prize). This breakthrough technology overcame international intellectual property barriers and developed the first high-end blood cell analyzer, the BC-6800, with functions to detect nucleated red blood cells and reticulocytes. The device has been successfully promoted to over 90% of tertiary hospitals in China. While detecting routine blood cell ratios, this blood cell analyzer actually generates a large amount of multi-modal data on cell distribution characteristics, including cell distribution width and abnormal cell ratios. However, so far, these multi-modal data have not been fully utilized in clinical practice.
Preliminary exploration of multi-modal cell data has demonstrated its enormous value in predicting, diagnosing, and prognosing infectious diseases in small populations. This study aims to retrospectively collect clinical data and blood cell multi-modal data from NICU and PICU hospitalized children in multiple centers across China, to establish a national multi-center blood cell multi-modal database with no less than 100,000 people, and to use artificial intelligence technology to achieve accurate, repeatable, and unbiased identification and classification based on differences in cell morphology and structural distribution. A high-performance prediction model will be constructed in the discovery cohort to predict the survival risk of critically ill children; the performance of the model will be validated in the validation cohort to evaluate its applicability in the Chinese population of critically ill children. This study will provide solid evidence for evidence-based medicine based on multi-center cohort studies and offer potential new inspection technologies for predicting the survival risk of critically ill children, providing auxiliary decision support for clinicians, improving the survival rate of critically ill children, and promoting the development of precision medicine.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ruowen He
- Phone Number: 13434240706
- Email: 1577576652@qq.com
Study Contact Backup
- Name: Jielin Huang
- Phone Number: 13686562550
- Email: HJielin2022@163.com
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510000
- Recruiting
- Zhujiang Hospital of Southern Medical University
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Contact:
- Hongwei Zhou, Professor
- Phone Number: 18688489622
- Email: hzhou@smu.edu.cn
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children who were admitted to NICU and PICU from January 1, 2018, to March 31, 2023.
- Age <18 years, gender not limited.
- Blood routine tests were performed using Mindray Medical's five-category blood cell analyzer (including BC6000, BC6000PLUS, BC6800PLUS, and BC7500 series), and the instrument or computer system retained relatively complete blood cell multi-modal data.
- Detailed clinical medical records related to this study can be obtained.
- Patients who were repeatedly admitted to NICU or PICU and had different conditions, causes, and outcomes each time were counted as new cases.
Exclusion Criteria:
- Children with congenital immunodeficiency.
- Children with blood diseases, including iron-deficiency anemia, macrocytic anemia, hereditary spherocytosis, glucose-6-phosphate dehydrogenase deficiency, thalassemia, autoimmune hemolytic anemia, aplastic anemia, immune thrombocytopenia, acute lymphoblastic leukemia, acute non-lymphoblastic leukemia, multiple myeloma, allergic purpura, myelodysplastic syndrome, etc.
- Children with genetic metabolic diseases, including galactosemia, mucopolysaccharidosis, glycogen storage disease, phenylketonuria, albinism, alkaptonuria, hypoxanthine-guanine phosphoribosyltransferase deficiency, chromhidrosis, Goucher disease, Tay-Sachs disease, etc.
- Children with chromosomal diseases, including Down syndrome, trisomy 18, etc.
- Children who received blood products within six months, including transfused blood components, human immunoglobulin, etc.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Group 1
No Intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
death
Time Frame: through study completion, an average of 1 month
|
diagnosis time based on medical records
|
through study completion, an average of 1 month
|
multiple organ dysfunction syndrome(MODS)
Time Frame: through study completion, an average of 1 month
|
diagnosis time based on medical records
|
through study completion, an average of 1 month
|
sepsis
Time Frame: through study completion, an average of 1 month
|
diagnosis time based on medical records
|
through study completion, an average of 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
disseminated intravascular coagulation(DIC)
Time Frame: through study completion, an average of 1 month
|
diagnosis time based on medical records
|
through study completion, an average of 1 month
|
chronic lung disease or acute respiratory distress syndrome
Time Frame: through study completion, an average of 1 month
|
diagnosis time based on medical records
|
through study completion, an average of 1 month
|
shock
Time Frame: through study completion, an average of 1 month
|
diagnosis time based on medical records
|
through study completion, an average of 1 month
|
Length of stay in the pediatric intensive care unit(PICU) or neonatal intensive care unit(NICU) hospitalization duration
Time Frame: through study completion, an average of 1 month
|
diagnosis time based on medical records
|
through study completion, an average of 1 month
|
brain injury or neurological complications
Time Frame: through study completion, an average of 1 month
|
diagnosis time based on medical records
|
through study completion, an average of 1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GPCRCLM0001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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