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Recruiting NCT02852031

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

Observational Hypoplastic Left Heart Syndrome (HLHS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Collaborative Learning Network.
Who it may be relevant to
Registry conditions: Hypoplastic Left Heart Syndrome (HLHS). Basic parameters: up to 15 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Other Collaborative Learning Network

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 61 centers
  • Children's of Alabama — Birmingham
  • Phoenix Children's Hospital — Phoenix
  • Arkansas Children's Hospital — Little Rock
  • Children's Hospital Los Angeles — Los Angeles
  • UCLA Mattel Children's Hospital — Los Angeles
  • Lucile Packard Children's Hospital-Stanford — Palo Alto
  • Sutter Medical Center-Sacramento — Sacramento
  • UC Davis Children's Hospital — Sacramento
  • … and 53 more centers
Canada · 1 center
  • The Hospital for Sick Kids- University of Toronto — Toronto
United Kingdom · 1 center
  • Evelina London Children's Healthcare — London

Identifiers

NCT: NCT02852031 · 2015-3866

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗