Understanding lung injury in young patients after heart surgery
Neutrophil Phenotypic Profiling and Acute Lung Injury in Patients After Cardiopulmonary Bypass (CPB)
Boston Children's Hospital · NCT04296071
This study looks at how heart surgery can cause lung injury in young patients by examining the role of certain immune cells to help improve their recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 56 (estimated) |
| Ages | N/A to 12 Months |
| Sex | All |
| Sponsor | Boston Children's Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04296071 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the mechanisms behind acute lung injury (ALI) that can occur in pediatric patients following cardiopulmonary bypass (CPB) during cardiac surgery. It focuses on the role of neutrophils, which are immune cells that can contribute to lung damage when activated during CPB. By analyzing the behavior and characteristics of these neutrophils, the study seeks to provide insights into how CPB affects lung function and potentially leads to serious complications like acute respiratory distress syndrome. The findings could help improve postoperative care and outcomes for affected patients.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients under 12 months of age who are scheduled for cardiac surgery requiring cardiopulmonary bypass.
Not a fit: Patients who are not undergoing cardiac surgery or those with preoperative oxygen saturation levels below 90% may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of lung injury in children undergoing heart surgery, potentially reducing complications and improving recovery times.
How similar studies have performed: While there is existing literature on lung injury post-CPB, this specific focus on neutrophil profiling in pediatric patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Are \< 12months of age * Scheduled for cardiac surgical needing CPB * Preoperative SpO2 \> 90% Exclusion Criteria: * Lack of parental (or legal guardian's) consent * Preoperative SpO2 \< 90% * Preoperative oxygen therapy
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Sophia Koutsogiannaki, PhD
- Email: sophia.koutsogiannaki@childrens.harvard.edu
- Phone: 617-919-4725
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lung Injury, Cardiopulmonary Bypass