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

NCT02852031 | Recruiting

• 1 other identifier: 2015-3866
• Study Type: observational
• Target: 1,000
• Locations: 3 countries
• Sites: 63

Brief 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.

Conditions

Hypoplastic Left Heart Syndrome (HLHS)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Hypoplastic Left Heart Syndrome

Infants diagnosed with Hypoplastic Left Heart Syndrome (HLHS)

Other: Collaborative Learning Network

Interventions

Collaborative Learning Network OTHER

Hypoplastic Left Heart Syndrome

Eligibility Criteria

• Age: Up to 15 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants diagnosed with HLHS

You may qualify if:

• Fetuses or newborns diagnosed with HLHS or other univentricular condition
• Intended to undergo Norwood procedure

You may not qualify if:

• None

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (63)

Children's of Alabama

Birmingham, Alabama, 35233, United States

COMPLETED

Phoenix Children's Hospital

Phoenix, Arizona, 85006, United States

RECRUITING

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

RECRUITING

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

UCLA Mattel Children's Hospital

Los Angeles, California, 90095, United States

RECRUITING

Lucile Packard Children's Hospital-Stanford

Palo Alto, California, 94304, United States

RECRUITING

Sutter Medical Center-Sacramento

Sacramento, California, 95816, United States

RECRUITING

UC Davis Children's Hospital

Sacramento, California, 95817, United States

RECRUITING

Rady Children's Hospital

San Diego, California, 92123, United States

RECRUITING

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Nemours Cardiac Center, A.I DuPont Hospital for Children

Wilmington, Delaware, 19803, United States

RECRUITING

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

University of Florida-UF Health

Gainesville, Florida, 32606, United States

RECRUITING

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

RECRUITING

Arnold Palmer Children's Hospital

Orlando, Florida, 32806, United States

RECRUITING

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

RECRUITING

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

RECRUITING

Ann and Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Advocate Children's Hospital

Oak Lawn, Illinois, 60453, United States

RECRUITING

Riley Hospital for Children at IU Health

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Iowa Children's Hospital

Iowa City, Iowa, 52242, United States

RECRUITING

Norton Children's Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

Ochsner Hospital For Children

Jefferson, Louisiana, 70121, United States

RECRUITING

Children's Hospital New Orleans

New Orleans, Louisiana, 70118, United States

RECRUITING

University of Maryland Children's Hospital

Baltimore, Maryland, 21201, United States

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

University of Michigan C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

RECRUITING

Children's Hospital and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

RECRUITING

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, 55454, United States

RECRUITING

Batson Children's Hospital-University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

RECRUITING

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

RECRUITING

Children's Hospital and Medical Center-Omaha

Omaha, Nebraska, 68114, United States

RECRUITING

Cohen Children's Medical Center Northwell Health

New Hyde Park, New York, 11040, United States

RECRUITING

NYU Medical Center

New York, New York, 10016, United States

RECRUITING

Columbia University- NY Presbyterian

New York, New York, 10032, United States

RECRUITING

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

The Children's Hospital of Montefiore

The Bronx, New York, 10467, United States

RECRUITING

Levine Children's Hospital-Sanger Heart and Vascular Institute

Charlotte, North Carolina, 28203, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27705, United States

RECRUITING

Akron Children's Hospital

Akron, Ohio, 44308, United States

ACTIVE NOT RECRUITING

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

RECRUITING

University Hospitals Case Medical Center - Rainbow Babies & Children's Hospital, Pediatric Heart Center

Cleveland, Ohio, 44092, United States

RECRUITING

Cleveland Clinic Children's Hospital

Cleveland, Ohio, 44195, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43023, United States

RECRUITING

Doernbecher Children's Hospital

Portland, Oregon, 97239, United States

RECRUITING

PennState Hershey Medical Center--PennState Health Children's Hospital

Harrisburg, Pennsylvania, 22908, United States

NOT YET RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

RECRUITING

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

RECRUITING

Children's Medical Center of Dallas

Dallas, Texas, 75235, United States

RECRUITING

Cook Childrens Medical Center

Fort Worth, Texas, 76104, United States

RECRUITING

Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

RECRUITING

UVA Children's Hospital

Charlottesville, Virginia, 22908, United States

RECRUITING

Inova Children's Hospital

Falls Church, Virginia, 22042, United States

RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

University of Wisconsin, American Family Children's

Madison, Wisconsin, 53792, United States

RECRUITING

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

RECRUITING

The Hospital for Sick Kids- University of Toronto

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

Evelina London Children's Healthcare

London, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Hypoplastic Left Heart Syndrome

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Garick Hill, MD

  Cininnati Children's Hospital Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Timbers

CONTACT

mark.timbers@cchmc.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: August 2, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); GB (1); US (61)