Immune Heterogeneity Before and After Cardiopulmonary Bypass in Children

NCT06214182 | Completed DMC

• 1 other identifier: 2023-IRB-0303-P-01
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Ventricular Septal Defect

Outcome Measures

Primary Outcomes (1)

• Expression of genes

  The gene expression in single cells of peripheral blood samples was detected

  From enrollment to the end of CPB at 3 days

Study Arms (3)

Group T1

T1 is before CPB.

Group T2

T2 is 2 hours after CPB.

Group T3

T3 is 3 days after CPB.

Eligibility Criteria

• Age: 31 Days - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Birth weight range: 2500-6000g;
• Operation duration \>90min;

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Heart Septal Defects, Ventricular

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 19, 2024
• Study Start: January 1, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 31, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

CN (1)