Immune Heterogeneity Before and After Cardiopulmonary Bypass in Children

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.

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Key information

Conditions

Ventricular Septal Defect Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Ventricular

Age range

31 day–1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

A Study of Immune Heterogeneity Before and After Cardiopulmonary Bypass in Children Undergoing Cardiac Surgery Based on ScRNA-seq

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jan 19, 2024
Registry last updated: Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed