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NCT04604418 · ClinicalTrials.gov registry record
Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
A clinical trial of Congenital Heart Disease in Children, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- 10,000
- Enrollment target
- 10
- Study locations
NCT04604418 is a study of Congenital Heart Disease in Children that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 10,000 participants, above the 351-participant average among 6 other Congenital Heart Disease in Children trials with a reported enrollment target (2749% higher). The trial reports 10 study locations across 10 states.
The verdict
NCT04604418, a study of Congenital Heart Disease in Children, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- 10,000 participants
- Enrollment target
- 10
- Study locations
Study 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.
Conditions Studied
Interventions
- OTHER No intervention. It is observational
Study Locations (10)
California
- University of California, Los Angeles - Los Angeles
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- Children's Healthcare of Atlanta - Egleston Hospita - Atlanta
Massachusetts
- Boston Children's Hospital - Boston
Minnesota
- University of Minnesota Medical Center - Minneapolis
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Tennessee
- Vanderbilt University Medical Center - Nashville
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,000 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2026-12-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04604418
The ClinicalTrials.gov registry entry for NCT04604418 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 10,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 351-participant average among 6 other Congenital Heart Disease in Children trials with a reported enrollment target (2749% higher). The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Congenital Heart Disease in Children appearing as the primary indexed condition, and to 1 intervention - of which No intervention. It is observational is the first listed.
NCT04604418 reports 10 study locations spanning 10 distinct geographic areas - top geographies include California, District of Columbia, Georgia.
Frequently Asked Questions
What is clinical trial NCT04604418 about?
NCT04604418 is a clinical study titled "Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures". 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 incr...
What is the current status of trial NCT04604418?
This trial is currently recruiting. The enrollment target is 10,000 participants. The study started on 2020-10-01. Estimated completion is 2026-12-31.
What conditions does trial NCT04604418 study?
This clinical trial studies the following conditions: Congenital Heart Disease in Children.
What interventions are being tested in trial NCT04604418?
The interventions under investigation include: No intervention. It is observational (OTHER).
Who is sponsoring clinical trial NCT04604418?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04604418 being conducted?
This trial has 10 study locations across California, District of Columbia, Georgia, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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