NCT04604418 Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
| NCT ID | NCT04604418 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Children's Hospital |
| Condition | Congenital Heart Disease in Children |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2020-10-01 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2020-10-01 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The incidence of moderate to severe congenital heart disease (CHD) in the United States is estimated to be 6 per 1000 live-born full term infants. Recent advances in pediatric cardiology, surgery and critical care have significantly improved the survival rates of patients with CHD leading to an increase in prevalence in both children and adults. Children with CHD significant enough to require cardiac surgery frequently also undergo non-cardiac surgical procedures. Analysis of the Pediatric Health Information System database between 2004 and 2012 demonstrated that 41% of children who had undergone surgery to correct CHD in the first year of life also underwent at least one non-cardiac surgery by age 5. With this increased demand for non-cardiac procedures, anesthesiologists, pediatricians and other healthcare providers will encounter patients with repaired or unrepaired CHD and other cardiac diseases in their practice. However, the information provided by national databases lack granularity and the information from single institutional data is limited. This project aims to address this knowledge gap in quantifying the risk for cardiac patients coming for noncardiac procedures and identify the health care resource utilization and system to best care for this patient population. To conduct this study, we will create a multi-institutional collaboration between large and small centers to create a unique dataset spanning all the different variables that need to be considered in risk prediction for these patients including patient variables, hospital setting, and providers. The aggregate multiinstitutional data set may be used for benchmarking for national quality improvement efforts.
Eligibility 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
Contact & Investigator
Viviane Nasr, MD
PRINCIPAL INVESTIGATOR
Boston Children's Hospital
Frequently Asked Questions
Who can join the NCT04604418 clinical trial?
This trial is open to participants of all sexes, up to 21 Years, studying Congenital Heart Disease in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04604418 currently recruiting?
Yes, NCT04604418 is actively recruiting participants. Contact the research team at viviane.nasr@childrens.harvard.edu for enrollment information.
Where is the NCT04604418 trial being conducted?
This trial is being conducted at Los Angeles, United States, Washington D.C., United States, Atlanta, United States, Boston, United States and 6 additional locations.
Who is sponsoring the NCT04604418 clinical trial?
NCT04604418 is sponsored by Boston Children's Hospital. The principal investigator is Viviane Nasr, MD at Boston Children's Hospital. The trial plans to enroll 10,000 participants.