Examining health outcomes in children with congenital heart disease undergoing non-cardiac procedures
Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
This study looks at how children with congenital heart disease do during and after non-heart surgeries to help doctors provide better care for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | N/A to 21 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 10 sites (Los Angeles, California and 9 other locations) |
| Trial ID | NCT04604418 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on children diagnosed with congenital heart disease (CHD) who are undergoing non-cardiac surgical or nonsurgical procedures. It aims to analyze health care resource utilization and outcomes in this population, given the increasing prevalence of CHD due to improved survival rates. By utilizing data from multiple prominent medical centers, the study seeks to provide insights into perioperative risks and adverse postoperative outcomes for these patients. The findings could help inform anesthesiologists and pediatricians in managing care for children with CHD during non-cardiac procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged birth to 21 years diagnosed with congenital heart disease who are scheduled for non-cardiac procedures.
Not a fit: Patients undergoing cardiac surgical procedures or catheterizations will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of perioperative risks in children with CHD, leading to improved patient management and outcomes.
How similar studies have performed: While there is limited data on similar observational studies, the increasing focus on perioperative outcomes in pediatric populations suggests potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males or females ages birth to 21 years. 2. Patients diagnosed with congenital heart disease 3. Patients undergoing a noncardiac procedure (surgical or nonsurgical) Exclusion Criteria: 1. Patients with congenial heart disease undergoing a cardiac surgical procedure including pacemakers. 2. Patients with congenital heart disease undergoing a catheterization(diagnostic or interventional) or an electrophysiology study
Where this trial is running
Los Angeles, California and 9 other locations
- University of California, Los Angeles — Los Angeles, California, United States (Active_not_recruiting)
- Children's National Medical Center — Washington D.C., District of Columbia, United States (Recruiting)
- Children's Healthcare of Atlanta - Egleston Hospita — Atlanta, Georgia, United States (Active_not_recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Minnesota Medical Center — Minneapolis, Minnesota, United States (Active_not_recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
- Children's Hospital of the King's Daughter — Norfolk, Virginia, United States (Terminated)
- Hospital for Sick Kids — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Viviane Nasr, MD — Boston Children's Hospital
- Study coordinator: Viviane Nasr, MD
- Email: viviane.nasr@childrens.harvard.edu
- Phone: 617-355-6225
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.