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

NCT ID: NCT02852031

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2028-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypoplastic Left Heart Syndrome (HLHS)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hypoplastic Left Heart Syndrome

Infants diagnosed with Hypoplastic Left Heart Syndrome (HLHS)

Collaborative Learning Network

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Collaborative Learning Network

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* None
Maximum Eligible Age

15 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Garick Hill, MD

Role: PRINCIPAL_INVESTIGATOR

Cininnati Children's Hospital Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's of Alabama

Birmingham, Alabama, United States

Site Status COMPLETED

Phoenix Children's Hospital

Phoenix, Arizona, United States

Site Status RECRUITING

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status RECRUITING

Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

UCLA Mattel Children's Hospital

Los Angeles, California, United States

Site Status RECRUITING

Lucile Packard Children's Hospital-Stanford

Palo Alto, California, United States

Site Status RECRUITING

Sutter Medical Center-Sacramento

Sacramento, California, United States

Site Status RECRUITING

UC Davis Children's Hospital

Sacramento, California, United States

Site Status RECRUITING

Rady Children's Hospital

San Diego, California, United States

Site Status RECRUITING

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status RECRUITING

Nemours Cardiac Center, A.I DuPont Hospital for Children

Wilmington, Delaware, United States

Site Status RECRUITING

Children's National Medical Center

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

Site Status RECRUITING

University of Florida-UF Health

Gainesville, Florida, United States

Site Status RECRUITING

Nicklaus Children's Hospital

Miami, Florida, United States

Site Status RECRUITING

Arnold Palmer Children's Hospital

Orlando, Florida, United States

Site Status RECRUITING

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Site Status RECRUITING

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status RECRUITING

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

Chicago, Illinois, United States

Site Status RECRUITING

Advocate Children's Hospital

Oak Lawn, Illinois, United States

Site Status RECRUITING

Riley Hospital for Children at IU Health

Indianapolis, Indiana, United States

Site Status RECRUITING

University of Iowa Children's Hospital

Iowa City, Iowa, United States

Site Status RECRUITING

Norton Children's Hospital

Louisville, Kentucky, United States

Site Status RECRUITING

Ochsner Hospital For Children

Jefferson, Louisiana, United States

Site Status RECRUITING

Children's Hospital New Orleans

New Orleans, Louisiana, United States

Site Status RECRUITING

University of Maryland Children's Hospital

Baltimore, Maryland, United States

Site Status RECRUITING

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

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

Ann Arbor, Michigan, United States

Site Status RECRUITING

Children's Hospital and Clinics of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, United States

Site Status RECRUITING

Batson Children's Hospital-University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status RECRUITING

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Site Status RECRUITING

St. Louis Children's Hospital

St Louis, Missouri, United States

Site Status RECRUITING

Children's Hospital and Medical Center-Omaha

Omaha, Nebraska, United States

Site Status RECRUITING

Cohen Children's Medical Center Northwell Health

New Hyde Park, New York, United States

Site Status RECRUITING

NYU Medical Center

New York, New York, United States

Site Status RECRUITING

Columbia University- NY Presbyterian

New York, New York, United States

Site Status RECRUITING

University of Rochester Medical Center

Rochester, New York, United States

Site Status RECRUITING

The Children's Hospital of Montefiore

The Bronx, New York, United States

Site Status RECRUITING

Levine Children's Hospital-Sanger Heart and Vascular Institute

Charlotte, North Carolina, United States

Site Status RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Akron Children's Hospital

Akron, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Site Status RECRUITING

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

Cleveland, Ohio, United States

Site Status RECRUITING

Cleveland Clinic Children's Hospital

Cleveland, Ohio, United States

Site Status RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status RECRUITING

Doernbecher Children's Hospital

Portland, Oregon, United States

Site Status RECRUITING

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

Harrisburg, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

Le Bonheur Children's Hospital

Memphis, Tennessee, United States

Site Status RECRUITING

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Site Status RECRUITING

Children's Medical Center of Dallas

Dallas, Texas, United States

Site Status RECRUITING

Cook Childrens Medical Center

Fort Worth, Texas, United States

Site Status RECRUITING

Texas Children's Hospital

Houston, Texas, United States

Site Status RECRUITING

Primary Children's Hospital

Salt Lake City, Utah, United States

Site Status RECRUITING

UVA Children's Hospital

Charlottesville, Virginia, United States

Site Status RECRUITING

Inova Children's Hospital

Falls Church, Virginia, United States

Site Status RECRUITING

Seattle Children's Hospital

Seattle, Washington, United States

Site Status RECRUITING

University of Wisconsin, American Family Children's

Madison, Wisconsin, United States

Site Status RECRUITING

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

The Hospital for Sick Kids- University of Toronto

Toronto, Ontario, Canada

Site Status RECRUITING

Evelina London Children's Healthcare

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Canada United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mark Timbers

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Joseph Graziano, MD

Role: primary

Cindy Carpenter

Role: primary

Jay Pruetz

Role: primary

Nancy Halnon

Role: primary

Kelly Kirby

Role: primary

650-815-8398

Michelle Agnew

Role: primary

916-262-9151

Mary Zanobini

Role: primary

(916) 734-0835

Jessica Haley, MD

Role: primary

858-966-5855

Mark Abcede, MBA

Role: backup

619-987-0560

Alison Artico Dumond

Role: primary

(720) 777-3366

Carol Prospero

Role: primary

302-651-6686

Sarah Clauss, MD

Role: primary

Dalia Lopez-Colon

Role: primary

352-281-6723

Madalsa Patel

Role: primary

Karen Iacono

Role: primary

407-497-7178

Courtney Hogan

Role: primary

727-767-3333

Sherry Smith

Role: primary

(404) 785-6792

Kathleen Van't Hoff

Role: primary

312-227-1549

Bonnie Hughes

Role: primary

(708)684-3772

Dana Hartman

Role: primary

(317) 274-8906

Trudy Pierick

Role: primary

(319) 384-8365

Ashley Rhinehart

Role: primary

Ivory Crittendon

Role: primary

504-842-5200

Thomas Kimball, MD

Role: primary

Beth Sherfy

Role: primary

(410) 328-0344

David Brown

Role: primary

Karen Uzark

Role: primary

(734) 615-9748

Jocelyn Berbee

Role: primary

612-813-8800

Kavisha Shah, MD

Role: primary

Stephanie Ghaleb

Role: primary

Lori Erickson

Role: primary

816-895-5083

Mayte Figueroa, MD

Role: primary

Jenny Strawn

Role: primary

(402) 955-4350

Elizabeth Vinas, RN, MD

Role: primary

718-470-3460

Ralph Mosca

Role: primary

Anne Ferris, MD

Role: primary

212-342-1560

Cecilia Meagher

Role: primary

Chelsie Cornelius

Role: primary

(718) 741-2543

Kari Crawford

Role: primary

(704) 381-3949

Michael Camitta, MD

Role: primary

Mark Timbers

Role: primary

Sarah Plummer

Role: primary

Francine Erenberg, MD

Role: primary

Holly Miller-Tate

Role: primary

(614) 722-2561

Christina Ronai

Role: primary

Julie Jones

Role: primary

(717) 531-8674

Alyson Stagg

Role: primary

(215) 435-6342

Cynthia Cardwell

Role: primary

412-692-6128

Frances Woodward

Role: primary

(843) 792-3289

Gina Guasco

Role: primary

David Parra, MD

Role: primary

Kimberly Moore

Role: primary

214-502-5294

Lisa Roten, MD

Role: primary

682-885-4195

Yvette Johnson, MD

Role: backup

817-347-9601

Rocky Tsang

Role: primary

Linda Lambert

Role: primary

(801) 662-5573

Leslie Peregoy

Role: primary

(434) 924-9119

Mechelle Fleischer

Role: primary

Titus Chan

Role: primary

Sharda Srinivasan, MD

Role: primary

608-263-1470

Karoline Canada, NP

Role: backup

615-364-7777

Nancy Rudd

Role: primary

(414) 266-3524

Alejandro Floh, MD

Role: primary

Roxanne Kirsch, MD

Role: backup

Aaron Bell, MD

Role: primary

4420 7188 4563

Hannah Bellsham-Revell, MD

Role: backup

447790 608820

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015-3866

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

SVRII Family Factors Study
NCT01582529 COMPLETED
PRecIsion Medicine in CardiomyopathY
NCT04036799 ACTIVE_NOT_RECRUITING
Mild Valvar Pulmonary Stenosis
NCT00277927 TERMINATED