NCT05862675

Brief 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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2023

Typical duration for all trials

Status
withdrawn

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

First Submitted

Initial submission to the registry

February 2, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 2, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

3.1 years

First QC Date

February 2, 2023

Last Update Submit

July 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Expression of differential genes and proteins through gene sequencing

    an average of 1week

Study Arms (2)

experimental group

meeting the specific diagnostic criteria for acute Lung Injury

Diagnostic Test: RNA sequencing of blood samples

control group

Healthy children

Interventions

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.

experimental group

Eligibility Criteria

Age1 Year - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 1-14 who were hospitalized in the Children's Hospital affiliated to Chongqing Medical University.

You may qualify if:

  • Clinical diagnosis of ALI/ARDS.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 32849610BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Collect blood, sputum or alveolar lavage fluid samples of subjects, extract RNA or DNA for relevant tests.

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Zhou Mi, Master

    Chongqing Medical University

    PRINCIPAL INVESTIGATOR
  • Ding Fengxia, Doctor

    Chongqing Medical University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending doctor

Study Record Dates

First Submitted

February 2, 2023

First Posted

May 17, 2023

Study Start

May 2, 2023

Primary Completion

May 30, 2026

Study Completion

May 30, 2026

Last Updated

July 11, 2023

Record last verified: 2023-07