National Collaborative to Improve Care of Children With Complex Congenital Heart Disease

Hypoplastic Left Heart Syndrome (HLHS) Clinical Trial

— NPC-QIC  

Official title:

National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) - A Collaborative Initiative to Improve Care of Children With Complex Congenital Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02852031
• Other study ID #: 2015-3866
• Status: Recruiting
• Start date: May 2016
• Est. completion date: May 2028

Study information

• Verified date: May 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Mark Timbers
• Email: mark.timbers[@]cchmc.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this initiative is to improve care and outcomes for infants with HLHS by expanding the NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between diagnosis and 12 months of age, by improving the use of standards into everyday practice across pediatric cardiology centers, and by engaging parents as partners in the process.

Description:

The purpose of this initiative is to improve care and outcomes for infants with HLHS by: 1) expanding the established NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between diagnosis and 12 months of age, 2) improving implementation of consensus standards, tested by teams, into everyday practice across pediatric cardiology centers, and 3) engaging parents as partners in improving care and outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 2028
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Months

Eligibility

Inclusion Criteria:

• Fetuses or newborns diagnosed with HLHS or other univentricular condition

• Intended to undergo Norwood procedure

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Heart Defects, Congenital
• Heart Diseases
• Hypoplastic Left Heart Syndrome
• Hypoplastic Left Heart Syndrome (HLHS)

Intervention

Other:
• Collaborative Learning Network

Locations

Country	Name	City	State
Canada	The Hospital for Sick Kids- University of Toronto	Toronto	Ontario
United Kingdom	Evelina London Children's Healthcare	London
United States	Akron Children's Hospital	Akron	Ohio
United States	University of Michigan C.S. Mott Children's Hospital	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	University of Maryland Children's Hospital	Baltimore	Maryland
United States	Children's of Alabama	Birmingham	Alabama
United States	Boston Children's Hospital	Boston	Massachusetts
United States	The Children's Hospital of Montefiore	Bronx	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Levine Children's Hospital-Sanger Heart and Vascular Institute	Charlotte	North Carolina
United States	UVA Children's Hospital	Charlottesville	Virginia
United States	Ann and Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Children's Hospital	Cleveland	Ohio
United States	University Hospitals Case Medical Center - Rainbow Babies & Children's Hospital, Pediatric Heart Center	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Children's Medical Center of Dallas	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova Children's Hospital	Falls Church	Virginia
United States	Cook Childrens Medical Center	Fort Worth	Texas
United States	University of Florida-UF Health	Gainesville	Florida
United States	PennState Hershey Medical Center--PennState Health Children's Hospital	Harrisburg	Pennsylvania
United States	Texas Children's Hospital	Houston	Texas
United States	Riley Hospital for Children at IU Health	Indianapolis	Indiana
United States	University of Iowa Children's Hospital	Iowa City	Iowa
United States	Batson Children's Hospital-University of Mississippi Medical Center	Jackson	Mississippi
United States	Ochsner Hospital For Children	Jefferson	Louisiana
United States	Children's Mercy Hospitals and Clinics	Kansas City	Missouri
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	UCLA Mattel Children's Hospital	Los Angeles	California
United States	Norton Children's Hospital	Louisville	Kentucky
United States	University of Wisconsin, American Family Children's	Madison	Wisconsin
United States	Le Bonheur Children's Hospital	Memphis	Tennessee
United States	Nicklaus Children's Hospital	Miami	Florida
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	Children's Hospital and Clinics of Minnesota	Minneapolis	Minnesota
United States	University of Minnesota Masonic Children's Hospital	Minneapolis	Minnesota
United States	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee
United States	Cohen Children's Medical Center Northwell Health	New Hyde Park	New York
United States	Children's Hospital New Orleans	New Orleans	Louisiana
United States	Columbia University- NY Presbyterian	New York	New York
United States	NYU Medical Center	New York	New York
United States	Advocate Children's Hospital	Oak Lawn	Illinois
United States	Children's Hospital and Medical Center-Omaha	Omaha	Nebraska
United States	Arnold Palmer Children's Hospital	Orlando	Florida
United States	Lucile Packard Children's Hospital-Stanford	Palo Alto	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	Doernbecher Children's Hospital	Portland	Oregon
United States	University of Rochester Medical Center	Rochester	New York
United States	Sutter Medical Center-Sacramento	Sacramento	California
United States	UC Davis Children's Hospital	Sacramento	California
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Johns Hopkins All Children's Hospital	Saint Petersburg	Florida
United States	Primary Children's Hospital	Salt Lake City	Utah
United States	Rady Children's Hospital	San Diego	California
United States	Seattle Children's Hospital	Seattle	Washington
United States	Children's National Medical Center	Washington	District of Columbia
United States	Nemours Cardiac Center, A.I DuPont Hospital for Children	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between the implementation of changes in care delivery with changes in the process	The purpose of this data sharing is to facilitate QI and research activities. As more information is gathered in this registry, the study team will determine the data analyses methods to determine if the knowledge gained led to changes in care delivery and/or to better patient outcomes.	15 months