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Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)

Comparing shunt and stent methods for newborn blood flow.

Recruiting
1-30 years
All
Phase N/A

The COMPASS Trial is a study for newborns with a special heart problem called ductal-dependent pulmonary blood flow. This means their blood needs help to get to the lungs. In this study, doctors want to find out which is better for these babies: a **shunt** or a **stent**. A **shunt** is a tiny tube that helps blood flow from one part of the body to another, and a **stent** is a small tube that keeps a blood vessel open. The study will check how each method works for the baby's first year.

  • The study lasts for the first year of the baby's life.
  • Babies are randomly chosen to get either the shunt or the stent.
  • Doctors will check the baby's health to see which method works best.

To join the study, babies must be 30 days old or younger and need a stable blood flow to the lungs. Some babies cannot join, like those with very complex heart issues or other serious health problems. The study will help doctors understand the best way to help these babies in the future.

Study details
    Congenital Heart Disease in Children

NCT05268094

Carelon Research

23 February 2025

Step 1 Get in touch with the nearest study center
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Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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