Recruiting

Observational StudyNational Collaborative to Improve Care of Children With Complex Congenital Heart Disease

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT02852031

Conditions

Hypoplastic Left Heart Syndrome (HLHS)

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Collaborative Learning Network

Study Details

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)

Study ID

NCT02852031

Start date

May, 2016

Status verified date

Jun, 2025

Completion date

May, 2028

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

None

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Hypoplastic Left Heart Syndrome

Infants diagnosed with Hypoplastic Left Heart Syndrome (HLHS)

Interventions

Collaborative Learning Network

Primary outcome measure

Relationship between the implementation of changes in care delivery with changes in the process [ Time Frame: 15 months ]

Central Contacts and Locations

Central contacts

Mark Timbers

mark.timbers@cchmc.org

Locations

Phoenix Children's Hospital

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Joseph Graziano, MD

jgraziano@phoenixchildrens.com

Principal Investigator:

Joseph Graziano, MD

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Cindy Carpenter

carpentercynthia@uams.edu

Principal Investigator:

Dala Zakaria, MD

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Jay Pruetz

jpruetz@chla.usc.edu

Principal Investigator:

Jay Pruetz, MD

UCLA Mattel Children's Hospital

Recruiting

Los Angeles, California, United States, 90095

Contacts

Nancy Halnon

nhalnon@mednet.ucla.edu

Principal Investigator:

Nancy Halnon, MD

Lucile Packard Children's Hospital-Stanford

Recruiting

Palo Alto, California, United States, 94304

Contacts

Kelly Kirby

650-815-8398 kkirby@stanfordchildrens.org

Principal Investigator:

Sharon Chen, MD

Sutter Medical Center-Sacramento

Recruiting

Sacramento, California, United States, 95816

Contacts

Michelle Agnew

916-262-9151 AgnewM@sutterhealth.org

Principal Investigator:

James Hill, MD

UC Davis Children's Hospital

Recruiting

Sacramento, California, United States, 95817

Contacts

Mary Zanobini

(916) 734-0835 mfzanobini@ucdavis.edu

Principal Investigator:

Andrew Pelech, MD

Rady Children's Hospital

Recruiting

San Diego, California, United States, 92123

Contacts

Jessica Haley, MD

858-966-5855 jhaley1@rchsd.org

Mark Abcede, MBA

619-987-0560 mabcede1@rchsd.org

Principal Investigator:

Jessica Haley, MD

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Alison Artico Dumond

(720) 777-3366 alison.artico@childrenscolorado.org

Principal Investigator:

Jonathan Kaufman, MD

Nemours Cardiac Center, A.I DuPont Hospital for Children

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Carol Prospero

302-651-6686 carol.prospero@nemours.org

Principal Investigator:

Erica Del Grippo, MD

Children's National Medical Center

Recruiting

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

Contacts

Sarah Clauss, MD

SClauss@childrensnational.org

Principal Investigator:

Sarah Clauss, MD

University of Florida-UF Health

Recruiting

Gainesville, Florida, United States, 32606

Contacts

Dalia Lopez-Colon

352-281-6723 dalylc@ufl.edu

Principal Investigator:

Jennifer Co-Vu, MD

Nicklaus Children's Hospital

Recruiting

Miami, Florida, United States, 33155

Contacts

Madalsa Patel

Madalsa.Patel@mch.com

Principal Investigator:

Madalsa Patel, MD

Arnold Palmer Children's Hospital

Recruiting

Orlando, Florida, United States, 32806

Contacts

Karen Iacono

407-497-7178 karen.iacono@orlandohealth.com

Principal Investigator:

Elise Riddle, MD

Johns Hopkins All Children's Hospital

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Courtney Hogan

727-767-3333 chogan2@jhmi.edu

Principal Investigator:

Benton Ng, MD

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Sherry Smith

(404) 785-6792 sherry.smith@choa.org

Principal Investigator:

Martha Clabby, MD

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

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Kathleen Van't Hoff

312-227-1549 kvanthof@luriechildrens.org

Principal Investigator:

Kiona Allen, MD

Advocate Children's Hospital

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Bonnie Hughes

(708)684-3772 bonnie.hughes@advocatehealth.com

Principal Investigator:

Andrew Vanbergen, MD

Riley Hospital for Children at IU Health

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Dana Hartman

(317) 274-8906 dmwellma@iupui.edu

Principal Investigator:

Anne Farrell, MD

University of Iowa Children's Hospital

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Trudy Pierick

(319) 384-8365 trudy-pierick@uiowa.edu

Principal Investigator:

Benjamin Reinking, MD

Norton Children's Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Ashley Rhinehart

ajrhin01@exchange.louisville.edu

Principal Investigator:

Edward Kim, MD

Ochsner Hospital For Children

Recruiting

Jefferson, Louisiana, United States, 70121

Contacts

Ivory Crittendon

504-842-5200 icrittendon@ochsner.org

Principal Investigator:

Ivory Crittendon, MD

Children's Hospital New Orleans

Recruiting

New Orleans, Louisiana, United States, 70118

Contacts

Thomas Kimball, MD

thomas.kimball@lcmchealth.org

Principal Investigator:

Thomas Kimball, MD

University of Maryland Children's Hospital

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Beth Sherfy

(410) 328-0344 bsherfy@umm.edu

Principal Investigator:

Alicia Chaves, MD

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

David Brown

david.brown@cardio.chboston.org

Principal Investigator:

David Brown, MD

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

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Karen Uzark

(734) 615-9748 karenu@med.umich.edu

Principal Investigator:

Katherine Bates, MD

Children's Hospital and Clinics of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Jocelyn Berbee

612-813-8800 JBerbee@chc-pa.org

Principal Investigator:

Christine Hills, MD

University of Minnesota Masonic Children's Hospital

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

Kavisha Shah, MD

kshah@umn.edu

Principal Investigator:

Kavisha Shah, MD

Batson Children's Hospital-University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Stephanie Ghaleb

sghaleb@umc.edu

Principal Investigator:

Stephanie Ghaleb

Children's Mercy Hospitals and Clinics

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Lori Erickson

816-895-5083 laerickson@cmh.edu

Principal Investigator:

Matthew Moehlmann, MD

St. Louis Children's Hospital

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Mayte Figueroa, MD

Figueroamaytei@wustl.edu

Principal Investigator:

Mayte Figueroa, MD

Children's Hospital and Medical Center-Omaha

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Jenny Strawn

(402) 955-4350 jstrawn@childrensomaha.org

Principal Investigator:

Christopher Curzon, DO

Cohen Children's Medical Center Northwell Health

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Elizabeth Vinas, RN, MD

718-470-3460 evinas@northwell.edu

Principal Investigator:

Elizabeth Vinas, RN, MD

NYU Medical Center

Recruiting

New York, New York, United States, 10016

Contacts

Ralph Mosca

ralph.mosca@nyulangone.org

Principal Investigator:

Ralph Mosca, MD

Columbia University- NY Presbyterian

Recruiting

New York, New York, United States, 10032

Contacts

Anne Ferris, MD

212-342-1560 af240@columbia.edu

Principal Investigator:

Anne Ferris, MD

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Cecilia Meagher

cecilia_meagher@urmc.rochester.edu

Principal Investigator:

Cecelia Meagher, MD

The Children's Hospital of Montefiore

Recruiting

The Bronx, New York, United States, 10467

Contacts

Chelsie Cornelius

(718) 741-2543 ccorneli@montefiore.org

Principal Investigator:

Nicole Sutton, MD

Levine Children's Hospital-Sanger Heart and Vascular Institute

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Kari Crawford

(704) 381-3949 kari.crawford@carolinashealthcare.org

Principal Investigator:

Amy Svenson, MD

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Michael Camitta, MD

michael.camitta@duke.edu

Principal Investigator:

Michael Camitta, MD

Cincinnati Children's Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Mark Timbers

mark.timbers@cchmc.org

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

Recruiting

Cleveland, Ohio, United States, 44092

Contacts

Sarah Plummer

sarah.plummer@uhhospitals.org

Principal Investigator:

Sarah Plummer, MD

Cleveland Clinic Children's Hospital

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Francine Erenberg, MD

Erenbef@ccf.org

Principal Investigator:

Francine Erenberg, MD

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43023

Contacts

Holly Miller-Tate

(614) 722-2561 holly.millertate@nationwidechildrens.org

Principal Investigator:

Richard Fernandez, MD

Doernbecher Children's Hospital

Recruiting

Portland, Oregon, United States, 97239

Contacts

Christina Ronai

ronai@ohsu.edu

Principal Investigator:

Christina Ronai, MD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Alyson Stagg

(215) 435-6342 stagga@email.chop.edu

Principal Investigator:

Therese Giglia, MD

Children's Hospital of Pittsburgh of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Cynthia Cardwell

412-692-6128 cynthia.cardwell@chp.edu

Principal Investigator:

Evon Morell, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Frances Woodward

(843) 792-3289 klinefl@musc.edu

Principal Investigator:

Frances Woodward, RN, PNP

Le Bonheur Children's Hospital

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Gina Guasco

gina.guasco@lebonheur.org

Principal Investigator:

Ranjit Raju Philip, MD

Monroe Carell Jr. Children's Hospital at Vanderbilt

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

David Parra, MD

david.parra@vumc.org

Principal Investigator:

David Parra, MD

Children's Medical Center of Dallas

Recruiting

Dallas, Texas, United States, 75235

Contacts

Kimberly Moore

214-502-5294 Kimberly.Moore@childrens.com

Principal Investigator:

Thomas Zellers, MD

Cook Childrens Medical Center

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Lisa Roten, MD

682-885-4195 Lisa.Roten@cookchildrens.org

Yvette Johnson, MD

817-347-9601 Yvette.Johnson@cookchildrens.org

Principal Investigator:

Lisa Roten, MD

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Rocky Tsang

rtsang@bcm.edu

Principal Investigator:

Elena Ocampo, MD

Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84113

Contacts

Linda Lambert

(801) 662-5573 Linda.lambert@hsc.utah.edu

Principal Investigator:

Dongngan Truong, MD

UVA Children's Hospital

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Leslie Peregoy

(434) 924-9119 lsp3ju@hscmail.mcc.virginia.edu

Principal Investigator:

Jeffrey Vergales, MD

Inova Children's Hospital

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Mechelle Fleischer

mechelle.fleischer@inova.org

Principal Investigator:

Harish Rudra, DO

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Titus Chan

titus.chan@seattlechildrens.org

Principal Investigator:

Titus Chan, MD

University of Wisconsin, American Family Children's

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Sharda Srinivasan, MD

608-263-1470 ssrinivasan3@wisc.edu

Karoline Canada, NP

615-364-7777 Kcanada@uwhealth.org

Principal Investigator:

Sharda Srivinivasan, MD

Children's Hospital of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53201

Contacts

Nancy Rudd

(414) 266-3524 nrudd@chw.org

Principal Investigator:

Nancy Rudd, MD

The Hospital for Sick Kids- University of Toronto

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Alejandro Floh, MD

alejandro.floh@sickkids.ca

Roxanne Kirsch, MD

roxanne.kirsch@sickkids.ca

Principal Investigator:

Alejandro Floh, MD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Jun 19, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2025-06-19.