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National Collaborative to Improve Care of Children With Complex Congenital Heart Disease (NPC-QIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02852031
Recruitment Status : Recruiting
First Posted : August 2, 2016
Last Update Posted : April 10, 2018
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment
Hypoplastic Left Heart Syndrome (HLHS) Other: Collaborative Learning Network

Detailed 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 15 Months
Official Title: National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) - A Collaborative Initiative to Improve Care of Children With Complex Congenital Heart Disease
Study Start Date : May 2016
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : May 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Group/Cohort Intervention/treatment
Infants diagnosed with HLHS
Other: Collaborative Learning Network

Primary Outcome Measures :
  1. Relationship between the implementation of changes in care delivery with changes in the process [ Time Frame: 15 months ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 15 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants diagnosed with HLHS

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02852031

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Contact: Bridget Butz (513)803-9166

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United States, Alabama
Children's of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Waldemar Carlo    205-934-3460   
Principal Investigator: Waldemar Carlo, MD         
United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85006
Contact: Courtney Howell    480-363-7192   
Principal Investigator: Amy Svenson, MD         
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Cindy Carpenter   
Principal Investigator: Michelle Moss, MD         
United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Hesham Mahmoud    323-361-5182   
Principal Investigator: Jay Pruetz         
UCLA Mattel Children's Hospital Recruiting
Los Angeles, California, United States, 90095
Contact: Ashley Abuel    310-267-7616   
Principal Investigator: Nancy Halnon, MD         
Lucile Packard Children's Hospital-Stanford Recruiting
Palo Alto, California, United States, 94304
Contact: Kelly Kirby    650-815-8398   
Principal Investigator: Gail Wright, MD         
Sutter Medical Center-Sacramento Recruiting
Sacramento, California, United States, 95816
Contact: Michelle Agnew    916-262-9151   
Principal Investigator: James Hill, MD         
UC Davis Children's Hospital Recruiting
Sacramento, California, United States, 95817
Contact: Mary Zanobini    916-734-0835   
Principal Investigator: Andrew Pelech, MD         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Alison Artico Dumond    720-777-3366   
Principal Investigator: Adel Younoszai, MD         
United States, Delaware
Nemours Cardiac Center, A.I DuPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Carol Prospero    302-651-6686   
Principal Investigator: Jose Ettedgui, MD         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Kathleen Reed    202-476-5759   
Principal Investigator: Sarah Clauss, MD         
United States, Florida
University of Florida-UF Health Recruiting
Gainesville, Florida, United States, 32606
Contact: Dalia Lopez-Colon    352-281-6723   
Principal Investigator: Jennifer Co-Vu, MD         
Joe Dimaggio Children's Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Julissa Escorcia    954-265-3437   
Principal Investigator: Kak-Chen Chan, MD         
Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Patel Madalsa   
Principal Investigator: Patel Madalsa, MD         
Arnold Palmer Children's Hospital Recruiting
Orlando, Florida, United States, 32806
Contact: Karen Iacono    407-497-7178   
Principal Investigator: Craig Fleishman, MD         
Johns Hopkins All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Courtney Hogan    727-767-3333   
United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Contact: Sherry Smith    404-785-6792   
Principal Investigator: Martha Clabby, MD         
United States, Illinois
Ann and Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Kathleen Van't Hoff    312-227-1549   
Principal Investigator: George Verghese, MD         
Advocate Children's Hospital Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Bonnie Hughes    708-684-3772   
Principal Investigator: Andrew Vanbergen, MD         
United States, Indiana
Riley Hospital for Children at IU Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Dana Hartman    317-274-8906   
Principal Investigator: Anne Farrell, MD         
United States, Iowa
University of Iowa Children's Hospital Recruiting
Iowa City, Iowa, United States, 52242
Contact: Trudy Pierick    319-384-8365   
Principal Investigator: Benjamin Reinking, MD         
United States, Kentucky
Norton Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Ashley Rhinehart   
Principal Investigator: Ryan Leahy, MD         
United States, Louisiana
Ochsner Hospital For Children Recruiting
Jefferson, Louisiana, United States, 70121
Contact: Ivory Crittendon    504-842-5200   
Principal Investigator: Ivory Crittendon, MD         
United States, Maryland
University of Maryland Children's Hospital Recruiting
Baltimore, Maryland, United States, 21201
Contact: Beth Sherfy    410-328-0344   
Principal Investigator: Alica Chaves, MD         
Johns Hopkins Hospital Not yet recruiting
Baltimore, Maryland, United States, 21205
Contact: Lasya Gaur, MD   
Principal Investigator: Lasya Gaur, MD         
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Terry Saia    617-355-8427   
Principal Investigator: David Brown, MD         
United States, Michigan
University of Michigan C.S. Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Karen Uzark    734-615-9748   
Principal Investigator: Katherine Bates, MD         
Principal Investigator: Sarah Gelehrter, MD         
United States, Minnesota
Children's Hospital and Clinics of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Jocelyn Berbee    612-813-8800   
Principal Investigator: Christine Hills, MD         
University of Minnesota Masonic Children's Hospital Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Rebecca Ameduri   
Principal Investigator: Rebecca Ameduri, MD         
United States, Mississippi
Baston Children's Hospital-University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Avichal Aggarwal, MD    601-984-5284   
Contact: Stacey Smith, RN    601-984-6873   
Principal Investigator: Avichal Aggarwal, MD         
United States, Missouri
Children's Mercy Hospitals and Clinics Recruiting
Kansas City, Missouri, United States, 64108
Contact: Lori Erickson    816-895-5083   
Principal Investigator: Amy Lay, MD         
St. Louis Children's Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Alison Cohen    314-286-0522   
Principal Investigator: Caroline Lee, MD         
United States, Nebraska
Children's Hospital and Medical Center-Omaha Recruiting
Omaha, Nebraska, United States, 68114
Contact: Jenny Strawn    402-955-4350   
Principal Investigator: John Kugler, MD         
United States, New York
The Children's Hospital of Montefiore Recruiting
Bronx, New York, United States, 10467
Contact: Chelsie Cornelius    718-741-2543   
Principal Investigator: Nicole Sutton, MD         
Cohen Children's Medical Center Northwell Health Not yet recruiting
New Hyde Park, New York, United States, 11040
Contact: Elizabeth Vinas, RN, MD    718-470-3460   
Principal Investigator: Elizabeth Vinas, RN, MD         
NYU Medical Center Recruiting
New York, New York, United States, 10016
Contact: Lincy George    718-612-2099   
Principal Investigator: Anne Chun, MD         
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Carolyn Dumar    585-275-4167   
Principal Investigator: Cecelia Meagher, MD         
United States, North Carolina
Levine Children's Hospital-Sanger Heart and Vascular Institute Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Kari Crawford    704-381-3949   
Principal Investigator: Resai Bengur, MD         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Bronwyn Bartle         
Principal Investigator: Michael Camitta, MD         
United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44308
Contact: Kathryn Wheller   
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Bridget Butz    513-803-9166   
University Hospitals Case Medical Center - Rainbow Babies & Children's Hospital, Pediatric Heart Center Recruiting
Cleveland, Ohio, United States, 44092
Contact: Jodi Zalewski    216-983-5261   
Principal Investigator: Nancy Dobrolet, MD         
Cleveland Clinic Children's Hospital Recruiting
Cleveland, Ohio, United States, 44195
Contact: Heta Shah Chaterjee    216-444-4313   
Principal Investigator: Francine Erenberg, MD         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43023
Contact: Holly Miller-Tate    614-722-2561   
Principal Investigator: Richard Fernandez, MD         
United States, Oregon
Doernbecher Children's Hospital Recruiting
Portland, Oregon, United States, 97239
Contact: Christina Ronai   
Principal Investigator: Christina Ronai, MD         
United States, Pennsylvania
PennState Hershey Medical Center--PennState Health Children's Hospital Not yet recruiting
Harrisburg, Pennsylvania, United States, 22908
Contact: Julie Jones    717-531-8674   
Principal Investigator: Vincent Aluquin, MD         
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Alyson Stagg    215-435-6342   
Principal Investigator: Therese Giglia, MD         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Evonne Morell, MD   
Contact: Cynthia Cardwell    412-692-6128   
Principal Investigator: Evon Morell, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Frances Woodward    843-792-3289   
Principal Investigator: Frances Woodward, RN         
United States, Tennessee
Le Bonheur Children's Hospital Recruiting
Memphis, Tennessee, United States, 38103
Contact: Liz Hoffmaster    901-287-5955   
Principal Investigator: Ranjit Philip, MD         
Monroe Carell Jr. Children's Hospital at Vanderbilt Recruiting
Nashville, Tennessee, United States, 37232
Contact: Karen Kohl    615-512-0359   
Principal Investigator: David Parra, MD         
United States, Texas
Children's Medical Center of Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Kimberly Moore    214-502-5294   
Principal Investigator: Thomas Zellers, MD         
Cook Childrens Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Lisa Rotten, MD    682-885-4195   
Contact: Yvette Johnson, MD    817-347-9601   
Principal Investigator: Lisa Rotten, MD         
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Sarah Sami    832-826-5931   
Principal Investigator: Elena Ocampo, MD         
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Linda Lambert    801-662-5573   
Principal Investigator: Dongngan Truong, MD         
United States, Virginia
UVA Children's Hospital Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Leslie Peregoy    434-924-9119   
Principal Investigator: Jeffrey Vergales, MD         
Inova Children's Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Mechelle Fleischer   
Principal Investigator: Harish Rudra, DO         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Titus Chan   
Principal Investigator: Titus Chan, MD         
United States, Wisconsin
University of Wisconsin, American Family Children's Not yet recruiting
Madison, Wisconsin, United States, 53792
Contact: Sharda Srinivasan, MD    608-263-1470   
Contact: Karoline Canada, NP    615-364-7777   
Principal Investigator: Sharda Srivinivasan, MD         
Sub-Investigator: Catherine Allen, MD         
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53201
Contact: Nancy Rudd    414-266-3524   
Principal Investigator: Garick Hill, MD         
Canada, Ontario
The Hospital for Sick Kids- University of Toronto Not yet recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Alejandro Floh, MD   
Contact: Roxanne Kirsch, MD   
Principal Investigator: Alejandro Floh, MD         
United Kingdom
Evelina London Children's Healthcare Not yet recruiting
London, United Kingdom
Contact: Aaron Bell, MD    4420 7188 4563   
Contact: Hannah Bellsham-Revell, MD    447790 608820   
Principal Investigator: Aaron Bell, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
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Principal Investigator: Jeffrey Anderson, MD Cininnati Children's Hospital Medical Center

Additional Information:

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Responsible Party: Children's Hospital Medical Center, Cincinnati Identifier: NCT02852031     History of Changes
Other Study ID Numbers: 2015-3866
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available.

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Hypoplastic Left Heart Syndrome
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities