Improving care for infants with complex heart conditions
National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) - A Collaborative Initiative to Improve Care of Children With Complex Congenital Heart Disease
This study is trying to improve the care and outcomes for infants with Hypoplastic Left Heart Syndrome by collecting important health information and involving parents in their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | N/A to 15 Months |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 63 sites (Birmingham, Alabama and 62 other locations) |
| Trial ID | NCT02852031 on ClinicalTrials.gov |
What this trial studies
This initiative aims to enhance the care and outcomes for infants diagnosed with Hypoplastic Left Heart Syndrome (HLHS) by expanding a national registry to collect clinical and developmental data. It focuses on implementing consensus standards into daily practices across pediatric cardiology centers and actively involves parents in the care process. The study will gather information on infants from diagnosis until they reach 12 months of age, facilitating better understanding and management of HLHS.
Who should consider this trial
Good fit: Ideal candidates for this initiative are fetuses or newborns diagnosed with HLHS or other univentricular conditions who are intended to undergo the Norwood procedure.
Not a fit: Patients who do not have HLHS or are not undergoing the Norwood procedure may not benefit from this initiative.
Why it matters
Potential benefit: If successful, this initiative could lead to improved health outcomes and quality of life for infants with HLHS.
How similar studies have performed: Other studies focusing on collaborative care and registry-based approaches have shown promise in improving outcomes for similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Fetuses or newborns diagnosed with HLHS or other univentricular condition * Intended to undergo Norwood procedure Exclusion Criteria: * None
Where this trial is running
Birmingham, Alabama and 62 other locations
- Children's of Alabama — Birmingham, Alabama, United States (Completed)
- Phoenix Children's Hospital — Phoenix, Arizona, United States (Recruiting)
- Arkansas Children's Hospital — Little Rock, Arkansas, United States (Recruiting)
- Children's Hospital Los Angeles — Los Angeles, California, United States (Recruiting)
- UCLA Mattel Children's Hospital — Los Angeles, California, United States (Recruiting)
- Lucile Packard Children's Hospital-Stanford — Palo Alto, California, United States (Recruiting)
- Sutter Medical Center-Sacramento — Sacramento, California, United States (Recruiting)
- UC Davis Children's Hospital — Sacramento, California, United States (Recruiting)
- Rady Children's Hospital — San Diego, California, United States (Recruiting)
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- Nemours Cardiac Center, A.I DuPont Hospital for Children — Wilmington, Delaware, United States (Recruiting)
- Children's National Medical Center — Washington D.C., District of Columbia, United States (Recruiting)
- University of Florida-UF Health — Gainesville, Florida, United States (Recruiting)
- Nicklaus Children's Hospital — Miami, Florida, United States (Recruiting)
- Arnold Palmer Children's Hospital — Orlando, Florida, United States (Recruiting)
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States (Recruiting)
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
- Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
- Advocate Children's Hospital — Oak Lawn, Illinois, United States (Recruiting)
- Riley Hospital for Children at IU Health — Indianapolis, Indiana, United States (Recruiting)
- University of Iowa Children's Hospital — Iowa City, Iowa, United States (Recruiting)
- Norton Children's Hospital — Louisville, Kentucky, United States (Recruiting)
- Ochsner Hospital For Children — Jefferson, Louisiana, United States (Recruiting)
- Children's Hospital New Orleans — New Orleans, Louisiana, United States (Recruiting)
- University of Maryland Children's Hospital — Baltimore, Maryland, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Michigan C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States (Recruiting)
- Children's Hospital and Clinics of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- University of Minnesota Masonic Children's Hospital — Minneapolis, Minnesota, United States (Recruiting)
- Batson Children's Hospital-University of Mississippi Medical Center — Jackson, Mississippi, United States (Recruiting)
- Children's Mercy Hospitals and Clinics — Kansas City, Missouri, United States (Recruiting)
- St. Louis Children's Hospital — St Louis, Missouri, United States (Recruiting)
- Children's Hospital and Medical Center-Omaha — Omaha, Nebraska, United States (Recruiting)
- Cohen Children's Medical Center Northwell Health — New Hyde Park, New York, United States (Recruiting)
- NYU Medical Center — New York, New York, United States (Recruiting)
- Columbia University- NY Presbyterian — New York, New York, United States (Recruiting)
- University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
- The Children's Hospital of Montefiore — The Bronx, New York, United States (Recruiting)
- Levine Children's Hospital-Sanger Heart and Vascular Institute — Charlotte, North Carolina, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- Akron Children's Hospital — Akron, Ohio, United States (Active_not_recruiting)
- Cincinnati Children's Hospital — Cincinnati, Ohio, United States (Recruiting)
- University Hospitals Case Medical Center - Rainbow Babies & Children's Hospital, Pediatric Heart Center — Cleveland, Ohio, United States (Recruiting)
- Cleveland Clinic Children's Hospital — Cleveland, Ohio, United States (Recruiting)
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
- Doernbecher Children's Hospital — Portland, Oregon, United States (Recruiting)
- PennState Hershey Medical Center--PennState Health Children's Hospital — Harrisburg, Pennsylvania, United States (Not_yet_recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
+13 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Garick Hill, MD — Cininnati Children's Hospital Medical Center
- Study coordinator: Mark Timbers
- Email: mark.timbers@cchmc.org
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.