The Role and Mechanism of Immune Regulation in Acute Lung Injury in Children

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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Lung Injury
• Intervention / Treatment: Diagnostic test: RNA sequencing of blood samples

Detailed 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.

• Study Type: Observational

Contacts and Locations

• Study Contact: Name: Liu Bo, Doctor; Phone Number: 15023331977; Email: lbcqmu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
experimental group; meeting the specific diagnostic criteria for acute Lung Injury	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.
control group; Healthy children

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expression of differential genes and proteins through gene sequencing	Detect patient gene expression through gene sequencing and analyze differential genes.	an average of 1week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary function	Pulmonary function tests were performed before and after infusion to evaluate the pulmonary function changes of subjects in the test group after infusion of exosomes to evaluate the long-term efficacy of exosomes in the treatment of lung diseases. Physiological parameter would be used to assess this outcome measure.	up to 2 weeks

Collaborators and Investigators

• Sponsor: Children's Hospital of Chongqing Medical University
• Investigators: Principal Investigator: Zhou Mi, Master, Chongqing Medical University; Principal Investigator: Ding Fengxia, Doctor, Chongqing Medical University

Publications and helpful links

General Publications

• 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.

Helpful Links

• In order to have a more comprehensive understanding of this article, this link is used to view the original reference.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 9, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Thoracic Injuries; Wounds and Injuries; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: ChongqingMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: If there is cooperation from other research centers in the future, this study will share patient clinical data and relevant clinical samples.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No