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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: Recruiting study of Congenital Heart Disease in Children, sponsored by Boston Children's Hospital.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Death

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

FieldValue
Enrollment Target 10,000 participants
Start Date 2020-10-01
Est. Completion 2026-12-31
Boston Children's Hospital

462 total trials

What NCT04604418 shows while recruiting

NCT04604418 is an observational study that tracks outcomes without assigning an intervention. Its 10,000 participants enrollment target places it among the larger protocols in the corpus, above the 351-participant average among 6 other Congenital Heart Disease in Children trials with a reported enrollment target (2749% higher).

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 lists 10 locations in 10 states (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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Source: ClinicalTrials.gov NCT04604418, the US trial registry maintained by the National Library of Medicine. NCT04604418 (large enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.