Clinical trial NCT05862675: The Role and Mechanism of Immune Regulation in Acute Lung Injury in Children
Official title: The Role and Mechanism of Immune Regulation in Acute Lung Injury in Children
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Lung Injury
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 1-14 who were hospitalized in the Children's Hospital affiliated to Chongqing Medical University.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Degree of inflammation in acute lung injury through measure physiological parameter
timeFrame: an average of 1week
Secondary outcomes:
measure: Expression of differential genes and proteins through gene sequencing
timeFrame: an average of 1week
Other outcomes:
Locations:
Study officials:
affiliation: Chongqing Medical University
name: Zhou Mi, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Chongqing Medical University
name: Ding Fengxia, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.