NCT06034639

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

August 11, 2023

Last Update Submit

September 12, 2023

Conditions

Children

Keywords

artificial Intelligencecritically ill childrensurvival Risk

Outcome Measures

Primary Outcomes (3)

  • death

    diagnosis time based on medical records

    through study completion, an average of 1 month

  • multiple organ dysfunction syndrome(MODS)

    diagnosis time based on medical records

    through study completion, an average of 1 month

  • sepsis

    diagnosis time based on medical records

    through study completion, an average of 1 month

Secondary Outcomes (5)

  • disseminated intravascular coagulation(DIC)

    through study completion, an average of 1 month

  • chronic lung disease or acute respiratory distress syndrome

    through study completion, an average of 1 month

  • shock

    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

    through study completion, an average of 1 month

  • brain injury or neurological complications

    through study completion, an average of 1 month

Study Arms (1)

Group 1

No Intervention

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

Central Study Contacts

Ruowen He

CONTACT

134342407061577576652@qq.com

Jielin Huang

CONTACT

13686562550HJielin2022@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
high professional title

Study Record Dates

First Submitted

August 11, 2023

First Posted

September 13, 2023

Study Start

March 1, 2023

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations

CN(1)