ChildrenNCT06034639
AI Based Multi-modal Parameter of Peripheral Blood Cells (MMPBC) Predicts Survival Risk in Critically Ill Children
An observational study of Children, run by Zhujiang Hospital at 1 site in China.
Trial summary
This study aims to investigate whether an AI prediction model based on blood cell multi-modal data can achieve early warning of survival risk in critically ill children through a large-scale multi-center cohort of critically ill children. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Children
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 30 Sep 2023
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The included population in this study consists of children who meet the following criteria: they were admitted to NICU and PICU between January 1, 2018, and March 31, 2023, and are under the age of 18 with no gender limitation. These children underwent blood routine tests using Mindray Medical's five-category blood cell analyzer, and the instrument or computer system retained relatively complete blood cell multi-modal data. Additionally, they have detailed clinical medical records related to this study. Excluded from the study are children with underlying blood, genetic, or chromosomal diseases, those who have received blood products in the past six months, and non-critically ill children who temporarily stayed in NICU or PICU due to bed availability issues in other wards.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
Hongwei Zhou, Professor, 18688489622, hzhou@smu.edu.cn
About this study
Official title: AI Based Multi-modal Parameter of Peripheral Blood Cells (MMPBC) Predicts Survival Risk in Critically Ill Children: a Multicenter, Retrospective Cohort Study
This study aims to investigate whether an AI prediction model based on blood cell multi-modal data can achieve early warning of survival risk in critically ill children through a large-scale multi-center cohort of critically ill children.
Read the 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.
- Conditions
- Children
- Keywords
- artificial Intelligence, critically ill children, survival Risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
diagnosis time based on medical records
Measured: through study completion, an average of 1 month
multiple organ dysfunction syndrome(MODS)
diagnosis time based on medical records
Measured: through study completion, an average of 1 month
sepsis
diagnosis time based on medical records
Measured: through study completion, an average of 1 month
Secondary outcomes (5)
disseminated intravascular coagulation(DIC)
diagnosis time based on medical records
Measured: through study completion, an average of 1 month
chronic lung disease or acute respiratory distress syndrome
diagnosis time based on medical records
Measured: through study completion, an average of 1 month
shock
diagnosis time based on medical records
Measured: 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
diagnosis time based on medical records
Measured: through study completion, an average of 1 month
brain injury or neurological complications
diagnosis time based on medical records
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Mar 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongwei Zhou, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034639
- Sponsor's protocol ID
- GPCRCLM0001
- Status last verified
- Sep 2023
- First submitted
- 11 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI Based Multi-modal Parameter of Peripheral Blood Cells (MMPBC) Predicts Survival Risk in Critically Ill Children: a Multicenter, Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06034639
- Acronym / sponsor ID
- GPCRCLM0001
- Conditions
- Children
- Keywords
- artificial Intelligence, critically ill children, survival Risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 13 Sep 2023 (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 aims to investigate whether an AI prediction model based on blood cell multi-modal data can achieve early warning of survival risk in critically ill children through a large-scale multi-center cohort of critically ill children.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –No Intervention |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The included population in this study consists of children who meet the following criteria: they were admitted to NICU and PICU between January 1, 2018, and March 31, 2023, and are under the age of 18 with no gender limitation. These children underwent blood routine tests using Mindray Medical's five-category blood cell analyzer, and the instrument or computer system retained relatively complete blood cell multi-modal data. Additionally, they have detailed clinical medical records related to this study. Excluded from the study are children with underlying blood, genetic, or chromosomal diseases, those who have received blood products in the past six months, and non-critically ill children who temporarily stayed in NICU or PICU due to bed availability issues in other wards.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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
death
Time frame: through study completion, an average of 1 month
diagnosis time based on medical records
multiple organ dysfunction syndrome(MODS)
Time frame: through study completion, an average of 1 month
diagnosis time based on medical records
sepsis
Time frame: through study completion, an average of 1 month
diagnosis time based on medical records
5 secondary outcomes
disseminated intravascular coagulation(DIC)
Time frame: 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
shock
Time frame: 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
brain injury or neurological complications
Time frame: through study completion, an average of 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 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.
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 Children, run by Zhujiang Hospital 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruowen He (13434240706, 1577576652@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: through study completion, an average of 1 month). The study lists 3 primary outcomes in all. 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 13 Sep 2023.