Actively Recruiting

Age: 0 - 21Years
All Genders
NCT04604418

Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures

Led by Boston Children's Hospital · Updated on 2026-04-07

10000

Participants Needed

10

Research Sites

326 weeks

Total Duration

On this page

Sponsors

B

Boston Children's Hospital

Lead Sponsor

T

The Hospital for Sick Children

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures

Who Can Participate

Age: 0 - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males or females ages birth to 21 years
  • Diagnosis of congenital heart disease
  • Scheduled for a non-cardiac procedure, either surgical or nonsurgical
Not Eligible

You will not qualify if you...

  • Undergoing cardiac surgery including pacemaker implantation
  • Undergoing cardiac catheterization (diagnostic or interventional) or electrophysiology study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

University of California, Los Angeles

Los Angeles, California, United States, 90095

Active, Not Recruiting

2

Children's National Medical Center

Washington D.C., District of Columbia, United States, 20310

Actively Recruiting

3

Children's Healthcare of Atlanta - Egleston Hospita

Atlanta, Georgia, United States, 30322

Active, Not Recruiting

4

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

5

University of Minnesota Medical Center

Minneapolis, Minnesota, United States, 55455

Active, Not Recruiting

6

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

7

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

8

Texas Children's Hospital

Houston, Texas, United States, 77030

Actively Recruiting

9

Children's Hospital of the King's Daughter

Norfolk, Virginia, United States, 23507

Terminated

10

Hospital for Sick Kids

Toronto, Ontario, Canada, M5G 1X8

Actively Recruiting

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Research Team

V

Viviane Nasr, MD

CONTACT

R

Rachel Bernier

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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