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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05862675
Other study ID # ChongqingMU
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date May 2, 2023
Est. completion date May 30, 2026

Study information

Verified date July 2023
Source Children's Hospital of Chongqing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Acute lung injury is a highly prevalent disease in children, posing a serious threat to their health and causing economic burden on society and families. It has received high attention. Blocking the cascade immune inflammatory response that occurs in the respiratory tract and finding key targets for the prevention and treatment of acute lung injury has become an important challenge faced by the medical community. The pathogenesis of acute lung injury is complex, involving the combined action of multiple cells and cytokines in the immune system. Therefore, it is necessary to further study the function of immune cells and specific immune pathogenesis, providing new ideas and theoretical basis for clinical treatment of acute lung injury. The omics technology includes Genomics, Transcriptome, proteomics, metabolomics, etc. Through qualitative and quantitative analysis of changes in low molecular weight molecules or metabolites of biological samples, it provides a new way to find biomarkers and pathogenesis. We plan to study the peripheral blood of children with acute lung injury and healthy children, and use network analysis to screen for differential genes and related enrichment pathways in acute lung injury. We aim to explore the correlation between immune regulation and inflammatory repair in children with acute lung injury, and analyze the regulatory mechanisms between immune cells related to it. Provide assistance for clinical diagnosis and treatment.


Description:

1. Inclusion criteria of the test group: (1) Meeting the specific diagnostic criteria for related lung diseases; (2) The factors of lung diseases were infection and sepsis; 2. Inclusion criteria of the control group: control 1: (1) Meeting the specific diagnostic criteria for related lung diseases; (2) The factors of lung diseases were non-infectious factors. Control 2: Healthy children 3. Exclusion criteria of the test group: (1) Patients with hemodynamic instability Patients with pulmonary hypertension;(2) Patients with congenital heart disease, congenital genetic metabolic disease, epilepsy, acute and chronic renal insufficiency, nephrotic syndrome, diabetes, et al. 4. The collection of clinical data includes: name, sex, age, hospitalization number, date of hospitalization, main diagnosis, course of disease, main examination and test results, medication, respiratory support, prognosis, etc. 5. Collect peripheral blood serum, sputum or alveolar lavage fluid samples for target sequencing.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 30, 2026
Est. primary completion date May 30, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 14 Years
Eligibility Inclusion Criteria: - Clinical diagnosis of ALI/ARDS. - Voluntary inclusion of researchers. Exclusion Criteria: - Patients with hemodynamic instability - Patients with pulmonary hypertension - Patients with congenital heart disease, congenital genetic metabolic disease, epilepsy, acute and chronic renal insufficiency, nephrotic syndrome, diabetes, etc.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
RNA sequencing of blood samples
Using omics techniques to detect blood samples from patients with acute lung injury and normal children, screen for marker genes related to immune cells in acute lung injury, and verify the protein expression of this molecule in tissues. Analyze the relationship between its phenotype and the degree of inflammation.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital of Chongqing Medical University

References & Publications (1)

Kumar V. Pulmonary Innate Immune Response Determines the Outcome of Inflammation During Pneumonia and Sepsis-Associated Acute Lung Injury. Front Immunol. 2020 Aug 4;11:1722. doi: 10.3389/fimmu.2020.01722. eCollection 2020. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Degree of inflammation in acute lung injury through measure physiological parameter The degree of inflammation includes changes in patient inflammatory indicators through measure physiological parameter. an average of 1week
Secondary Expression of differential genes and proteins through gene sequencing Detect patient gene expression through gene sequencing and analyze differential genes. an average of 1week
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