Acute Lung InjuryNCT05862675
The Role and Mechanism of Immune Regulation in Acute Lung Injury in Children
An observational study of Acute Lung Injury, run by Children's Hospital of Chongqing Medical University.
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. Read more about this study
- Who is it for?
- Ages 1 year to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- RNA sequencing of blood samples
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 2 May 2023to 30 May 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 1-14 who were hospitalized in the Children's Hospital affiliated to Chongqing Medical University.
Who may be able to join
- Clinical diagnosis of ALI/ARDS.
- Voluntary inclusion of researchers.
Who cannot join
- 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.
About this study
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.
Read the detailed description
- 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;
- 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
- 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.
- 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.
- Collect peripheral blood serum, sputum or alveolar lavage fluid samples for target sequencing.
- Conditions
- Acute Lung Injury
- Being tested
- RNA sequencing of blood samples
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNA sequencing of blood samplesDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | meeting the specific diagnostic criteria for acute Lung Injury Receives: Diagnostic Test: RNA sequencing of blood samples | |
| control group | Healthy children |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: an average of 1week
Secondary outcomes (1)
Expression of differential genes and proteins through gene sequencing
Detect patient gene expression through gene sequencing and analyze differential genes.
Measured: an average of 1week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start2 May 2023
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Why it stopped: Due to a time conflict in the research, the project research has been temporarily suspended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo liu, Children's Hospital of Chongqing Medical University
- Investigators
- Zhou Mi, Master, Principal investigator, Chongqing Medical UniversityDing Fengxia, Doctor, Principal investigator, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862675
- Sponsor's protocol ID
- ChongqingMU
- Status last verified
- Jul 2023
- First submitted
- 2 Feb 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If there is cooperation from other research centers in the future, this study will share patient clinical data and relevant clinical samples.
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.
PubMed 32849610
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role and Mechanism of Immune Regulation in Acute Lung Injury in Children
- ClinicalTrials.gov ID
- NCT05862675
- Acronym / sponsor ID
- ChongqingMU
- Conditions
- Acute Lung Injury
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to a time conflict in the research, the project research has been temporarily suspended.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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;
- 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
- 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.
- 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.
- Collect peripheral blood serum, sputum or alveolar lavage fluid samples for target sequencing.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Diagnostic Test: RNA sequencing of blood samplesmeeting the specific diagnostic criteria for acute Lung Injury |
| control group | – | –Healthy children |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 1-14 who were hospitalized in the Children's Hospital affiliated to Chongqing Medical University.
Key inclusion criteria (2 listed)
- Clinical diagnosis of ALI/ARDS.
- Voluntary inclusion of researchers.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RNA sequencing of blood samplesUsing 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. | Diagnostic test | experimental group |
Primary outcome
Degree of inflammation in acute lung injury through measure physiological parameter
Time frame: an average of 1week
The degree of inflammation includes changes in patient inflammatory indicators through measure physiological parameter.
1 secondary outcome
Expression of differential genes and proteins through gene sequencing
Time frame: an average of 1week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Background: PubMed 32849610Kumar 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.
- In order to have a more comprehensive understanding of this article, this link is used to view the original reference.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. If there is cooperation from other research centers in the future, this study will share patient clinical data and relevant clinical samples.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhou Mi, Master principal investigator
Chongqing Medical University
Ding Fengxia, Doctor principal investigator
Chongqing Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lung Injury, run by Children's Hospital of Chongqing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of inflammation in acute lung injury through measure physiological parameter (time frame: an average of 1week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05862675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.