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RecruitingOBSERVATIONAL

Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures

This study is about children and young people, up to 21 years old, who have a heart condition they were born with (congenital heart disease) and need other medical procedures not directly on their heart. We know that more children with heart conditions are living longer, and many will need other types of operations or medical tests as they grow up. The aim is to understand the risks these patients face during non-heart-related procedures and to identify the best ways hospitals can care for them. Researchers will collect information from many hospitals to learn more about how to provide the best and safest care for these young patients.

At a glance

Status
Recruiting
Sponsor
Boston Children's Hospital
Enrolment target
10,000
Start
01 Oct 2020
Estimated completion
31 Dec 2026

What is this study about?

You might be wondering what this study is all about. Well, it focuses on children and young people, from birth up to 21 years old, who were born with a heart condition, often called congenital heart disease (CHD). Thanks to amazing progress in heart care for children, more and more young people with CHD are growing up and living full lives.

Because these young people are living longer, they often need other medical procedures, like operations or special tests, that aren't directly about their heart. For example, they might need surgery for their tonsils, or for a broken bone. This study aims to understand how these non-heart procedures affect children with CHD and what kind of support and care they need from hospitals.

The researchers will gather information from many different hospitals, both big and small. By looking at a lot of patient records, they hope to get a clearer picture of how to best look after these young patients during non-heart procedures. This information can then help doctors, nurses, and hospitals improve their care and make these procedures as safe as possible for children with heart conditions.

Key takeaways

  • This study focuses on children and young people with heart conditions.
  • It looks at what happens when they have medical procedures not related to their heart.
  • No new treatments or tests are involved for patients.
  • Researchers will review existing medical records from many hospitals.
  • The goal is to improve safety and care for these young patients.
  • The study helps doctors understand necessary resources.

Who may be eligible?

This study is looking for information from a wide range of young people. If you are a male or female between birth and 21 years old and have been diagnosed with a heart condition you were born with (congenital heart disease), you might be included.

The key is that the study is specifically looking at patients who are having a medical procedure (either an operation or a non-surgical test) that is *not* directly on their heart.

You would not be included if your procedure is directly on your heart, such as heart surgery (including pacemakers), or special heart tests like a catheterization or an electrophysiology study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Is the person between birth and 21 years old?
  2. Do they have a heart condition they were born with?
  3. Are they having a medical procedure (like an operation or test) that is *not* on their heart?
  4. Are they *not* having heart surgery or a heart-specific test like a catheterization?
Answer every question to see your result.

What does participation involve?

Because this is an 'observational' study, it means you or your child won't be asked to do anything new or different. The researchers will simply be looking at existing medical records from different hospitals. There are no extra hospital visits, no new tests, no medications to take, and no special follow-up appointments required. Your doctors will continue to provide care exactly as they normally would. The study just involves looking at the information that has already been collected during your or your child's routine care.

Potential risks and benefits

Since this study only involves looking at existing medical records, there are no direct risks to you or your child. You won't be asked to change any part of your or your child's medical care. The potential benefit is that the information gathered from many patients can help doctors and hospitals understand how to provide better and safer care for children with heart conditions who need other medical procedures. This could lead to improved guidelines and resources for future patients. You always have the right to decide whether information from your or your child's medical records can be used for research, and your medical care will not be affected by this decision.

Locations (10)

  • University of California, Los Angeles
    Verified postcode
    Los Angeles, United States· Active not recruiting
  • Children's National Medical Center
    Verified postcode
    Washington D.C., United States· Recruiting
  • Children's Healthcare of Atlanta - Egleston Hospita
    Verified postcode
    Atlanta, United States· Active not recruiting
  • Boston Children's Hospital
    Verified postcode
    Boston, United States· Recruiting
  • University of Minnesota Medical Center
    Verified postcode
    Minneapolis, United States· Active not recruiting
  • Children's Hospital of Philadelphia
    Verified postcode
    Philadelphia, United States· Recruiting
  • Vanderbilt University Medical Center
    Verified postcode
    Nashville, United States· Recruiting
  • Texas Children's Hospital
    Verified postcode
    Houston, United States· Recruiting
  • Children's Hospital of the King's Daughter
    Verified postcode
    Norfolk, United States· Terminated
  • Hospital for Sick Kids
    Verified postcode
    Toronto, Canada· Recruiting

Common questions

What is a 'congenital heart disease'?

It means a heart problem that someone is born with.

What kind of children are in this study?

Children and young people from birth up to 21 years old who have a heart condition they were born with.

What does 'non-cardiac procedure' mean?

It means any medical procedure or operation that is not directly on the heart.

Will my child have to do anything extra?

No, this study just looks at existing medical records, so there are no extra tests or appointments.

How does this study help?

It helps medical teams better understand and improve the care for children with heart conditions who need other medical procedures.

How to find out more

Viviane Nasr, MD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Outcomes and Health Care Resource Utilization in Pediatric C…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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