National Collaborative to Improve Care of Children With Complex Congenital Heart Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 15
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fetuses or newborns diagnosed with HLHS or other univentricular condition
Intended to undergo Norwood procedure
Disqualifiers
None
Trial population
Infants diagnosed with HLHS
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Collaborative Learning Network
Other intervention
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Hypoplastic Left Heart Syndrome1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
15 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov