RecruitingOBSERVATIONAL

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

This project is called the "National Collaborative to Improve Care of Children With Complex Congenital Heart Disease." It focuses on babies born with a specific and serious heart condition known as Hypoplastic Left Heart Syndrome (HLHS). The main goal is to make sure these babies receive the best possible care and have better health outcomes. To achieve this, the project expands a national registry to collect important details about their treatment, development, and progress from diagnosis until they are 12 months old. It also encourages children's heart centres across the country to adopt the most up-to-date and effective care standards. A crucial part of this initiative is working closely with parents, including them as key partners in improving care.

At a glance

Status

Recruiting

Sponsor

Children's Hospital Medical Center, Cincinnati

Enrolment target

1,000

Start

01 May 2016

Estimated completion

01 May 2028

Hypoplastic Left Heart Syndrome (HLHS)

What is this study about?

This important national project is all about improving the care for babies born with a serious heart condition called Hypoplastic Left Heart Syndrome (HLHS). This condition means that the left side of the heart isn't fully developed, making it very difficult for the heart to pump blood effectively to the rest of the body.

The project has several key aims. Firstly, it's collecting detailed information from different children's heart centres across the country. This information includes how babies with HLHS are being cared for, how they are developing, and what their health outcomes are from the time they are diagnosed until they are about one year old. By gathering all this data, experts can learn what works best and identify areas where care can be improved.

Secondly, the project aims to help hospitals and medical teams use the very best and most up-to-date practices consistently. This means taking what is known to be the most effective care and making sure it's part of everyday treatment. Finally, and very importantly, parents are seen as crucial partners in this project. By involving parents, the project ensures that improvements in care truly meet the needs of families and their children.

Key takeaways

A national project focused on improving care for babies with HLHS.
Collects anonymous information on treatment and development up to 12 months of age.
Aims to help hospitals use the best practices for HLHS care.
Involves parents as partners in improving care.
No changes to your child's medical treatment if you participate.
Your child's information is kept private and you can withdraw at any time.

Who may be eligible?

This project is looking for certain babies to include. Generally, it's for babies who have been diagnosed, either before birth or shortly after, with Hypoplastic Left Heart Syndrome (HLHS) or a similar condition where only one side of the heart works properly.

To be considered for inclusion, it's also expected that the baby will be undergoing a specific heart operation called the Norwood procedure, which is a common first surgery for HLHS.

There are no specific reasons that would automatically exclude a baby from being considered for this project, other than not meeting the above criteria.

Quick self-check

Is your baby diagnosed with Hypoplastic Left Heart Syndrome (HLHS)?
Or a similar condition where only one side of the heart is working?
Is it planned for your baby to have the Norwood heart operation?
Is your baby between birth and 15 months old?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this project primarily involves your child's medical information being collected and shared, in an anonymous way, with the national registry. This includes details about their diagnosis, the treatments they receive, their progress, and their development up to 12 months of age. You wouldn't need to make extra visits or change any of their planned medical appointments or medications due to this project. The information would be gathered from their routine hospital visits and medical records. The total duration of data collection for your child would be from their diagnosis up to when they are 15 months old.

Potential risks and benefits

The main benefit of taking part is contributing valuable information that helps improve care for all babies with HLHS in the future. There are no direct medical benefits to your child from participating, as their treatment would not change. Because the project focuses on collecting existing medical information, there are no physical risks involved. Your child will not be given any new treatments or tests as part of this project. You always have the right to withdraw your child's data from the registry at any time, without it affecting their medical care.

Locations (63)

Children's of Alabama
Birmingham, United States· Completed
Phoenix Children's Hospital
Phoenix, United States· Recruiting
Arkansas Children's Hospital
Little Rock, United States· Recruiting
Children's Hospital Los Angeles
Los Angeles, United States· Recruiting
UCLA Mattel Children's Hospital
Los Angeles, United States· Recruiting
Lucile Packard Children's Hospital-Stanford
Palo Alto, United States· Recruiting
Sutter Medical Center-Sacramento
Sacramento, United States· Recruiting
UC Davis Children's Hospital
Sacramento, United States· Recruiting
Rady Children's Hospital
San Diego, United States· Recruiting
Children's Hospital Colorado
Aurora, United States· Recruiting
Nemours Cardiac Center, A.I DuPont Hospital for Children
Wilmington, United States· Recruiting
Children's National Medical Center
Washington D.C., United States· Recruiting

+51 more sites — see the official record for the full list.

Common questions

What is Hypoplastic Left Heart Syndrome (HLHS)?

HLHS is a serious heart condition where the left side of a baby's heart is underdeveloped and can't pump enough blood effectively to the body. It requires complex medical care, often including surgery.

Will my child's treatment change if we join this project?

No, your child's medical treatment will not change because of this project. They will continue to receive the best care as decided by their medical team. This project just gathers information about that care.

What kind of information is being collected?

The project collects details about your child's diagnosis, the care they receive, their health outcomes, and their development up to 12 months of age. This information helps understand what works best.

Is my child's personal information kept private?

Yes, personal information is kept very private. The data collected for the registry is anonymized, meaning your child's name and other identifying details are removed to protect their privacy.

Can I decide not to participate after agreeing?

Yes, you can choose to withdraw your child's information from the project at any time. This decision will not affect the medical care your child receives.

How to find out more

Mark Timbers

mark.timbers@cchmc.org Official trial record

Always speak to your GP or specialist before deciding to take part in a study.