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Hypoplastic Left Heart Syndrome (HLHS)NPC-QICNCT02852031

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

An observational study of Hypoplastic Left Heart Syndrome (HLHS), run by Children's Hospital Medical Center, Cincinnati at 63 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages Up to 15 months
Conditions the study is for
Hypoplastic Left Heart Syndrome (HLHS)
What is being tested?
Collaborative Learning Network
How many people
1,000 participants
Where
63 sitesin 3 countries
Study dates
May 2016to May 2028
How long will I take part?
15 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 15 months
  • All sexes
  • No healthy volunteers
  • Child

Study population: Infants diagnosed with HLHS

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

63 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Mark Timbers contact

mark.timbers@cchmc.org

63 sites in 3 countries

United States61 sites, 59 recruiting

  • Akron Children's Hospital

    Akron, Ohio, 44308

    Active, not recruiting

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

    Ann Arbor, Michigan, 48109

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

    Katherine Bates, MD

    Recruiting

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322

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

    Martha Clabby, MD

    Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

    Alison Artico Dumond, (720) 777-3366, alison.artico@childrenscolorado.org

    Jonathan Kaufman, MD

    Recruiting

  • University of Maryland Children's Hospital

    Baltimore, Maryland, 21201

    Beth Sherfy, (410) 328-0344, bsherfy@umm.edu

    Alicia Chaves, MD

    Recruiting

  • Children's of Alabama

    Birmingham, Alabama, 35233

    Completed

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

    David Brown, david.brown@cardio.chboston.org

    David Brown, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Frances Woodward, (843) 792-3289, klinefl@musc.edu

    Frances Woodward, RN, PNP

    Recruiting

  • Levine Children's Hospital-Sanger Heart and Vascular Institute

    Charlotte, North Carolina, 28203

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

    Amy Svenson, MD

    Recruiting

  • UVA Children's Hospital

    Charlottesville, Virginia, 22908

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

    Jeffrey Vergales, MD

    Recruiting

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

    Chicago, Illinois, 60611

    Kathleen Van't Hoff, 312-227-1549, kvanthof@luriechildrens.org

    Kiona Allen, MD

    Recruiting

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229

    Mark Timbers, mark.timbers@cchmc.org

    Recruiting

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

    Cleveland, Ohio, 44092

    Sarah Plummer, sarah.plummer@uhhospitals.org

    Sarah Plummer, MD

    Recruiting

  • Cleveland Clinic Children's Hospital

    Cleveland, Ohio, 44195

    Francine Erenberg, MD, Erenbef@ccf.org

    Francine Erenberg, MD

    Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio, 43023

    Holly Miller-Tate, (614) 722-2561, holly.millertate@nationwidechildrens.org

    Richard Fernandez, MD

    Recruiting

  • Children's Medical Center of Dallas

    Dallas, Texas, 75235

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

    Thomas Zellers, MD

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27705

    Michael Camitta, MD, michael.camitta@duke.edu

    Michael Camitta, MD

    Recruiting

  • Inova Children's Hospital

    Falls Church, Virginia, 22042

    Mechelle Fleischer, mechelle.fleischer@inova.org

    Harish Rudra, DO

    Recruiting

  • Cook Childrens Medical Center

    Fort Worth, Texas, 76104

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

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

    Recruiting

  • University of Florida-UF Health

    Gainesville, Florida, 32606

    Dalia Lopez-Colon, 352-281-6723, dalylc@ufl.edu

    Jennifer Co-Vu, MD

    Recruiting

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

    Harrisburg, Pennsylvania, 22908

    Julie Jones, (717) 531-8674, jjones6@hmc.psu.edu

    Vincent Aluquin, MD

    Not yet recruiting

  • Texas Children's Hospital

    Houston, Texas, 77030

    Rocky Tsang, rtsang@bcm.edu

    Elena Ocampo, MD

    Recruiting

  • Riley Hospital for Children at IU Health

    Indianapolis, Indiana, 46202

    Dana Hartman, (317) 274-8906, dmwellma@iupui.edu

    Anne Farrell, MD

    Recruiting

  • University of Iowa Children's Hospital

    Iowa City, Iowa, 52242

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

    Benjamin Reinking, MD

    Recruiting

  • Batson Children's Hospital-University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Stephanie Ghaleb, sghaleb@umc.edu

    Stephanie Ghaleb

    Recruiting

  • Ochsner Hospital For Children

    Jefferson, Louisiana, 70121

    Ivory Crittendon, 504-842-5200, icrittendon@ochsner.org

    Ivory Crittendon, MD

    Recruiting

  • Children's Mercy Hospitals and Clinics

    Kansas City, Missouri, 64108

    Lori Erickson, 816-895-5083, laerickson@cmh.edu

    Matthew Moehlmann, MD

    Recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202

    Cindy Carpenter, carpentercynthia@uams.edu

    Dala Zakaria, MD

    Recruiting

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

    Jay Pruetz, jpruetz@chla.usc.edu

    Jay Pruetz, MD

    Recruiting

  • UCLA Mattel Children's Hospital

    Los Angeles, California, 90095

    Nancy Halnon, nhalnon@mednet.ucla.edu

    Nancy Halnon, MD

    Recruiting

  • Norton Children's Hospital

    Louisville, Kentucky, 40202

    Ashley Rhinehart, ajrhin01@exchange.louisville.edu

    Edward Kim, MD

    Recruiting

  • University of Wisconsin, American Family Children's

    Madison, Wisconsin, 53792

    Sharda Srinivasan, MD, 608-263-1470, ssrinivasan3@wisc.edu

    Karoline Canada, NP, 615-364-7777, Kcanada@uwhealth.org

    Recruiting

  • Le Bonheur Children's Hospital

    Memphis, Tennessee, 38103

    Gina Guasco, gina.guasco@lebonheur.org

    Ranjit Raju Philip, MD

    Recruiting

  • Nicklaus Children's Hospital

    Miami, Florida, 33155

    Madalsa Patel, Madalsa.Patel@mch.com

    Madalsa Patel, MD

    Recruiting

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53201

    Nancy Rudd, (414) 266-3524, nrudd@chw.org

    Nancy Rudd, MD

    Recruiting

  • Children's Hospital and Clinics of Minnesota

    Minneapolis, Minnesota, 55404

    Jocelyn Berbee, 612-813-8800, JBerbee@chc-pa.org

    Christine Hills, MD

    Recruiting

  • University of Minnesota Masonic Children's Hospital

    Minneapolis, Minnesota, 55454

    Kavisha Shah, MD, kshah@umn.edu

    Kavisha Shah, MD

    Recruiting

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    Nashville, Tennessee, 37232

    David Parra, MD, david.parra@vumc.org

    David Parra, MD

    Recruiting

  • Cohen Children's Medical Center Northwell Health

    New Hyde Park, New York, 11040

    Elizabeth Vinas, RN, MD, 718-470-3460, evinas@northwell.edu

    Elizabeth Vinas, RN, MD

    Recruiting

  • Children's Hospital New Orleans

    New Orleans, Louisiana, 70118

    Thomas Kimball, MD, thomas.kimball@lcmchealth.org

    Thomas Kimball, MD

    Recruiting

  • NYU Medical Center

    New York, New York, 10016

    Ralph Mosca, ralph.mosca@nyulangone.org

    Ralph Mosca, MD

    Recruiting

  • Columbia University- NY Presbyterian

    New York, New York, 10032

    Anne Ferris, MD, 212-342-1560, af240@columbia.edu

    Anne Ferris, MD

    Recruiting

  • Advocate Children's Hospital

    Oak Lawn, Illinois, 60453

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

    Andrew Vanbergen, MD

    Recruiting

  • Children's Hospital and Medical Center-Omaha

    Omaha, Nebraska, 68114

    Jenny Strawn, (402) 955-4350, jstrawn@childrensomaha.org

    Christopher Curzon, DO

    Recruiting

  • Arnold Palmer Children's Hospital

    Orlando, Florida, 32806

    Karen Iacono, 407-497-7178, karen.iacono@orlandohealth.com

    Elise Riddle, MD

    Recruiting

  • Lucile Packard Children's Hospital-Stanford

    Palo Alto, California, 94304

    Kelly Kirby, 650-815-8398, kkirby@stanfordchildrens.org

    Sharon Chen, MD

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

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

    Therese Giglia, MD

    Recruiting

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85006

    Joseph Graziano, MD, jgraziano@phoenixchildrens.com

    Joseph Graziano, MD

    Recruiting

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224

    Cynthia Cardwell, 412-692-6128, cynthia.cardwell@chp.edu

    Evon Morell, MD

    Recruiting

  • Doernbecher Children's Hospital

    Portland, Oregon, 97239

    Christina Ronai, ronai@ohsu.edu

    Christina Ronai, MD

    Recruiting

  • University of Rochester Medical Center

    Rochester, New York, 14642

    Cecilia Meagher, cecilia_meagher@urmc.rochester.edu

    Cecelia Meagher, MD

    Recruiting

  • Sutter Medical Center-Sacramento

    Sacramento, California, 95816

    Michelle Agnew, 916-262-9151, AgnewM@sutterhealth.org

    James Hill, MD

    Recruiting

  • UC Davis Children's Hospital

    Sacramento, California, 95817

    Mary Zanobini, (916) 734-0835, mfzanobini@ucdavis.edu

    Andrew Pelech, MD

    Recruiting

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113

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

    Dongngan Truong, MD

    Recruiting

  • Rady Children's Hospital

    San Diego, California, 92123

    Jessica Haley, MD, 858-966-5855, jhaley1@rchsd.org

    Mark Abcede, MBA, 619-987-0560, mabcede1@rchsd.org

    Recruiting

  • Seattle Children's Hospital

    Seattle, Washington, 98105

    Titus Chan, titus.chan@seattlechildrens.org

    Titus Chan, MD

    Recruiting

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110

    Mayte Figueroa, MD, Figueroamaytei@wustl.edu

    Mayte Figueroa, MD

    Recruiting

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701

    Courtney Hogan, 727-767-3333, chogan2@jhmi.edu

    Benton Ng, MD

    Recruiting

  • The Children's Hospital of Montefiore

    The Bronx, New York, 10467

    Chelsie Cornelius, (718) 741-2543, ccorneli@montefiore.org

    Nicole Sutton, MD

    Recruiting

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

    Sarah Clauss, MD, SClauss@childrensnational.org

    Sarah Clauss, MD

    Recruiting

  • Nemours Cardiac Center, A.I DuPont Hospital for Children

    Wilmington, Delaware, 19803

    Carol Prospero, 302-651-6686, carol.prospero@nemours.org

    Erica Del Grippo, MD

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • The Hospital for Sick Kids- University of Toronto

    Toronto, Ontario, M5G 1X8

    Alejandro Floh, MD, alejandro.floh@sickkids.ca

    Roxanne Kirsch, MD, roxanne.kirsch@sickkids.ca

    Recruiting

Other trials in Canada

United Kingdom1 site, 1 recruiting

  • Evelina London Children's Healthcare

    London

    Aaron Bell, MD, 4420 7188 4563, Aaron.bell@gstt.nhs.uk

    Hannah Bellsham-Revell, MD, 447790 608820, Hannah.bellsham-revell@gstt.nhs.uk

    Not yet recruiting

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
Collaborative Learning Network
Medical subject headings
Hypoplastic Left Heart Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collaborative Learning NetworkOther

Study groups in NCT02852031
Study groupRoleWhat they receive
Hypoplastic Left Heart SyndromeInfants diagnosed with Hypoplastic Left Heart Syndrome (HLHS)
Receives: Other: Collaborative Learning Network

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionMay 2026 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
Target duration
15 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02852031
Sponsor's protocol ID
2015-3866
Acronym
NPC-QIC
Status last verified
Jun 2025
First submitted
19 May 2016
Last updated
19 Jun 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No: There is no plan to make individual participant data available.

Publications

  • Lin K, Foote HP, Camitta M, Liu B, Lydon E, Hong H, Peterson A, Sethi N, Shea EV, Turi J, Hill KD. Outcomes in infants with restrictive atrial septum and pre-stage 1 palliation septal intervention. Am Heart J. 2026 Oct 1;303:107620. doi: 10.1016/j.ahj.2026.107620. Online ahead of print.

    PubMed 42822816

Questions about this trial

What is this clinical trial studying?

An observational study of Hypoplastic Left Heart Syndrome (HLHS), run by Children's Hospital Medical Center, Cincinnati at 63 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mark Timbers (mark.timbers@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relationship between the implementation of changes in care delivery with changes in the process (time frame: 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02852031, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.

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