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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.
 
ClinicalTrials.gov Identifier: NCT02852031
Recruitment Status : Recruiting
First Posted : August 2, 2016
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Description
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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.
Study Design
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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


Groups and Cohorts
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Group/Cohort Intervention/treatment
Hypoplastic Left Heart Syndrome
Infants diagnosed with Hypoplastic Left Heart Syndrome (HLHS)
 Other: Collaborative Learning Network


Outcome Measures
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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.


Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02852031


Contacts
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Contact: Bridget Butz (513)803-9166 bridget.butz@cchmc.org

Locations
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Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Jeffrey Anderson, MD Cininnati Children's Hospital Medical Center
More Information
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Additional Information:

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02852031    
Other Study ID Numbers: 2015-3866
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021
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