1000 Participants Needed

Collaborative Learning for HLHS

(NPC-QIC Trial)

Recruiting at 73 trial locations
BB
LB
MT
Overseen ByMark Timbers
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital Medical Center, Cincinnati
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for infants with Hypoplastic Left Heart Syndrome (HLHS), a severe condition where the left side of the heart is underdeveloped. By collecting data and collaborating with pediatric cardiology centers through a Collaborative Learning Network, the trial seeks to enhance treatment standards and involve parents in the care process. It focuses on infants diagnosed with HLHS or similar heart issues who are scheduled for the Norwood procedure. The goal is to improve health outcomes and development from diagnosis up to the first year of life. As an unphased trial, this study offers families a unique opportunity to contribute to pioneering research aimed at enhancing care for future generations.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this Collaborative Learning Network is safe for infants with HLHS?

Research has shown that the Collaborative Learning Network, which improves outcomes for infants with Hypoplastic Left Heart Syndrome (HLHS), is safe and well-tolerated. A large study involving 5,000 infants with HLHS demonstrated that this approach is widely used without major safety issues. Additionally, these networks have effectively reduced serious safety incidents by 50%. This evidence suggests that the treatment is generally safe for infants.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to improve care for infants with Hypoplastic Left Heart Syndrome (HLHS) through a Collaborative Learning Network. Unlike traditional treatments, which often focus solely on surgical interventions and medical management, this approach emphasizes shared learning and collaboration among healthcare providers, potentially leading to faster advancements in care techniques and outcomes. By fostering communication and partnership, this network aims to create more standardized and effective treatment protocols, ultimately improving survival rates and quality of life for these young patients.

What evidence suggests that this Collaborative Learning Network is effective for improving care and outcomes for infants with HLHS?

Studies have shown that joining a Collaborative Learning Network, evaluated in this trial, can greatly improve outcomes for infants with hypoplastic left heart syndrome (HLHS). Research indicates that these networks use shared knowledge and experiences to enhance care practices. This approach has been linked to better survival rates during the critical period between heart surgeries. Specifically, the National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) demonstrated the power of these networks in improving care for infants with HLHS. Overall, evidence supports that Collaborative Learning Networks effectively enhance treatment and care for this condition.56789

Who Is on the Research Team?

GH

Garick Hill, MD

Principal Investigator

Cininnati Children's Hospital Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Data on clinical care process, outcome, and developmental data on infants with HLHS is gathered

12 months

Follow-up

Participants are monitored for safety and effectiveness after data collection

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Collaborative Learning Network
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Hypoplastic Left Heart SyndromeExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials
844
Recruited
6,566,000+

Citations

Rationale and methodology of a collaborative learning project ...The Single Ventricle Reconstruction Trial, which examined the outcomes of infants with hypoplastic left heart syndrome palliated with 2 different operative ...
Power of a Learning Network in Congenital Heart DiseaseThe National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) formed to improve outcomes in infants with hypoplastic left heart syndrome.
National pediatric cardiology quality improvement ...The initial project selected for this learning network is focused on care processes and outcomes of the initial interstage period for infants with hypoplastic ...
A National Pediatric Learning Health System (PEDSnet)We propose to create a national, pediatric-specific learning health system (LHS) composed of a newly formed multi-institutional clinical data research network ...
Improvement in Interstage Survival in a National Pediatric ...Evolution of treatment options and outcomes for hypoplastic left heart syndrome over an 18-year period. J Thorac Cardiovasc Surg. 2010;139:119–126 ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/32417078/
Improved National Outcomes Achieved in a Cardiac Learning ...A learning health network developed to improve outcomes for patients with hypoplastic left heart syndrome and variants, we assessed which centers contributed ...
NPC-QIC Enrolls 5000 Patients Into Its Registry of Babies ...This collection of data from 5000 babies makes it the largest known registry of infants with HLHS.
Improved National Outcomes Achieved in a Cardiac ...Within the National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC), a learning health network developed to improve outcomes for patients ...
Bringing Patients, Clinicians, and Researchers Together to ...LHNs have also demonstrated effectiveness in improving outcomes by decreasing serious safety events by 50 percent, reducing hypoplastic left ...
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