Ventricular Septal DefectNCT06214182
Immune Heterogeneity Before and After Cardiopulmonary Bypass in Children
An observational study of Ventricular Septal Defect, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
The goal of this observational study is to learn about functional heterogeneity of immune cells before and after cardiopulmonary bypass (CPB) in children with congenital heart disease (CHD). Read more about this study
- Who is it for?
- Ages 31 days to 1 year
- Conditions the study is for
- Ventricular Septal Defect
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Jan 2025
- How long will I take part?
- 30 Days
- 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 31 days to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: In this study, children aged 31d-1y who underwent subCPB ventricular septal defect repair for the first time between January 2024 and February 2024 at the Children's Hospital Affiliated to Zhejiang University School of Medicine were enrolled. This study will comply with the requirements set out in the Declaration of Helsinki and will be approved by the Ethics Committee of our Institute.
Who may be able to join
- Birth weight range: 2500-6000g;
- Operation duration >90min;
Who cannot join
- preterm infants or preoperative infections;
- systemic immune diseases and serious complications: such as rheumatoid arthritis, systemic lupus erythematosus, severe liver and kidney function damage, leukemia, etc.;
- Patients who have received an organ transplant;
- Patients who have received immunomodulatory drugs: patients who have received immunomodulatory drugs before surgery;
- Parents refused to participate or were unable to provide sufficient samples: Parents or legal guardians refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
About this study
Official title: A Study of Immune Heterogeneity Before and After Cardiopulmonary Bypass in Children Undergoing Cardiac Surgery Based on ScRNA-seq
The goal of this observational study is to learn about functional heterogeneity of immune cells before and after cardiopulmonary bypass (CPB) in children with congenital heart disease (CHD). The main question[s] it aims to answer are:
- Does CPB cause immune paralysis after CHD surgery?
- How does the functional heterogeneity of immune cells change before and after CPB in children undergoing CHD surgery? Participants will receive 3ml of peripheral blood before CPB, 2 hours after CPB, and 3 days after CPB, and the peripheral blood samples will be sequenced by single cell to explore the immune heterogeneity before and after CPB.
Read the detailed description
CPB-induced immune paralysis is the main cause of postoperative infection in CHD, which seriously affects the prognosis of children. The underlying mechanism of CPB-induced immune paralysis has not been fully determined. This study intends to use scRNA-seq to describe gene transcription profiles of immune cells in peripheral blood of children undergoing CHD surgery before and after CPB, and explore the differences within and between different immune cell populations including T cells and the changes of immune cells in different sequences. To fill the gap in the study of immune mechanism in CPB-induced immune paralysis microenvironment at single-cell resolution.
- Conditions
- Ventricular Septal Defect
- Medical subject headings
- Heart Septal Defects, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group T1 | T1 is before CPB. | |
| Group T2 | T2 is 2 hours after CPB. | |
| Group T3 | T3 is 3 days after CPB. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of genes
The gene expression in single cells of peripheral blood samples was detected
Measured: From enrollment to the end of CPB at 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Jan 2024
- Primary completion30 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Septal DefectStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenyuan Zhang, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214182
- Sponsor's protocol ID
- 2023-IRB-0303-P-01
- Status last verified
- Mar 2025
- First submitted
- 10 Jan 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Immune Heterogeneity Before and After Cardiopulmonary Bypass in Children Undergoing Cardiac Surgery Based on ScRNA-seq
- ClinicalTrials.gov ID
- NCT06214182
- Acronym / sponsor ID
- 2023-IRB-0303-P-01
- Conditions
- Ventricular Septal Defect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 19 Jan 2024 (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.
The goal of this observational study is to learn about functional heterogeneity of immune cells before and after cardiopulmonary bypass (CPB) in children with congenital heart disease (CHD). The main question[s] it aims to answer are:
- Does CPB cause immune paralysis after CHD surgery?
- How does the functional heterogeneity of immune cells change before and after CPB in children undergoing CHD surgery? Participants will receive 3ml of peripheral blood before CPB, 2 hours after CPB, and 3 days after CPB, and the peripheral blood samples will be sequenced by single cell to explore the immune heterogeneity before and after CPB.
Detailed description
CPB-induced immune paralysis is the main cause of postoperative infection in CHD, which seriously affects the prognosis of children. The underlying mechanism of CPB-induced immune paralysis has not been fully determined. This study intends to use scRNA-seq to describe gene transcription profiles of immune cells in peripheral blood of children undergoing CHD surgery before and after CPB, and explore the differences within and between different immune cell populations including T cells and the changes of immune cells in different sequences. To fill the gap in the study of immune mechanism in CPB-induced immune paralysis microenvironment at single-cell resolution.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group T1 | – | –T1 is before CPB. |
| Group T2 | – | –T2 is 2 hours after CPB. |
| Group T3 | – | –T3 is 3 days after CPB. |
Who may qualify
- Ages
- 31 days to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- In this study, children aged 31d-1y who underwent subCPB ventricular septal defect repair for the first time between January 2024 and February 2024 at the Children's Hospital Affiliated to Zhejiang University School of Medicine were enrolled. This study will comply with the requirements set out in the Declaration of Helsinki and will be approved by the Ethics Committee of our Institute.
Key inclusion criteria (2 listed)
- Birth weight range: 2500-6000g;
- Operation duration >90min;
Key exclusion criteria (5 listed)
- preterm infants or preoperative infections;
- systemic immune diseases and serious complications: such as rheumatoid arthritis, systemic lupus erythematosus, severe liver and kidney function damage, leukemia, etc.;
- Patients who have received an organ transplant;
- Patients who have received immunomodulatory drugs: patients who have received immunomodulatory drugs before surgery;
- Parents refused to participate or were unable to provide sufficient samples: Parents or legal guardians refused to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Expression of genes
Time frame: From enrollment to the end of CPB at 3 days
The gene expression in single cells of peripheral blood samples was detected
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Septal Defect, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
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 5 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: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Expression of genes (time frame: From enrollment to the end of CPB at 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2025.