About This Study

COmparison of Methods of Pulmonary blood flow Augmentation in neonates: Shunt versus Stent (The COMPASS Trial) - A prospective multicenter randomized interventional trial The purpose of this study is to compare outcomes in newborns with congenital heart disease and ductal-dependent pulmonary blood flow who are treated with either catheter-based ductal artery stent (DAS) implantation or surgical systemic-to pulmonary artery shunt (SPS).  

Study Locations

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In some babies born with congenital heart disease (CHD), the flow of blood between the heart and the lungs does not follow the usual pathway, called “ductal-dependent pulmonary blood flow.” A duct is like a passageway that allows blood to travel and pick up oxygen in the lungs. It is recommended that babies with ductal-dependent blood flow undergo a procedure to reduce the chance that this duct closes unexpectedly.

There are two common options to prevent early closure of the duct. One is a surgery, where a surgeon will place a passageway called a systemic-to-pulmonary artery shunt. The other is cardiac catheterization, where a doctor will place a ductal arterial stent, which gives off a drug designed to help them work better. The purpose of the COMPASS trial is to learn if one of the two options (stent or shunt) is better than the other.

Children < 30 days old with congenital heart disease and ductal-dependent pulmonary blood flow.

The study will be explained to you in detail by one of the study investigators. Once your questions have been answered, you will be asked to sign an informed consent form to enter the study.

Before your child’s first procedure we will:

  • Review your child’s medical records, including echocardiograms, CT scans, or cardiac MRIs to determine if they’re eligible to be a part of this study. We will ask you if you and your child would like to provide a blood and/or saliva sample for future research. Before your child’s first procedure, your child will be randomly assigned to have either the ductal arterial stent procedure or systemic-to-pulmonary artery shunt procedure.

After your child’s first procedure we will:

  • Review images and reports from the imaging tests that were performed as part of your child’s medical care, including echocardiograms, CT scans, cardiac MRIs, and images that were done during cardiac catheterization. We will obtain information and reports that were performed as part of your child’s normal medical care, including information on growth, as well as from cardiac catheterizations and/or surgeries, in the Intensive Care Unit, and the rest of hospitalization. This information will be collected during the first hospitalization, during your child’s second surgery and that hospitalization, any other time your child is admitted to the hospital, and at one year of age.

Your child will participate until one year of age.

When we finish the study, we hope to know more about treatment outcomes for children with ductal-dependent pulmonary blood flow. We expect that the results of the study will help improve the care of future babies born with ductal-dependent pulmonary blood flow.

We cannot promise any direct benefits to your child or others from you being in this study.

The possible risks of participating in this study include:

  • Risks related to the shunt or stent procedure itself
  • Potential for bruising or a small amount of bleeding during blood collection for Biobank
  • Loss of confidentiality
  • Genetic testing/analysis
  • Mild pressure on chest from probe during echocardiogram, and/or minor skin irritation from sticky patches placed on skin.

We will tell you about any new information that may affect your or your child’s health, welfare, or choice to stay in the research.

There will be no extra costs to you if your child is in the study. Your insurance will not be billed for any research-only activities. You are responsible for costs related to your child’s normal medical care, such as your child’s surgeries, hospital stays, medicines, lab tests, and doctor’s fees.