Clinical Trials

The National Heart, Lung, and Blood Institute (NHLBI) is strongly committed to supporting research aimed at preventing and treating heart, lung, and blood diseases and conditions and sleep disorders.

NHLBI-supported research has led to many advances in medical knowledge and care. For example, this research has uncovered some of the causes of heart diseases and conditions, as well as ways to prevent or treat them.

Many more questions remain about heart diseases and conditions, including patent ductus arteriosus (PDA) and other congenital heart defects. The NHLBI continues to support research aimed at learning more about these conditions. For example, the NHLBI currently sponsors two research groups that study congenital heart disease.

The Pediatric Heart Network conducts clinical research to improve outcomes and quality of life for children who have congenital heart disease and other pediatric heart diseases.

The Pediatric Cardiac Genomic Consortium (part of the NHLBI's Bench to Bassinet Program) conducts clinical research to find the genetic causes of congenital heart disease. This group's research also aims to pinpoint the genetic factors that affect clinical outcomes in people who have congenital heart disease.

Much of this research depends on the willingness of volunteers to take part in clinical trials. Clinical trials test new ways to prevent, diagnose, or treat various diseases and conditions.

For example, new treatments for a disease or condition (such as medicines, medical devices, surgeries, or procedures) are tested in volunteers who have the illness. Testing shows whether a treatment is safe and effective in humans before it is made available for widespread use.

By taking part in a clinical trial, your child can gain access to new treatments before they're widely available. Your child also will have the support of a team of health care providers, who will likely monitor his or her health closely. Even if your child doesn't directly benefit from the results of a clinical trial, the information gathered can help others and add to scientific knowledge.

Children (aged 18 and younger) get special protection as research subjects. Almost always, parents must give legal consent for their child to take part in a clinical trial.

When researchers think that a trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials.

If you agree to have your child take part in a clinical trial, you'll be asked to sign an informed consent form. This form is not a contract. You have the right to withdraw your child from a study at any time, for any reason. Also, you have the right to learn about new risks or findings that emerge during the trial.

For more information about clinical trials related to PDA, talk with your child's doctor. For more information about clinical trials for children, visit the NHLBI's Children and Clinical Studies Web page.

You also can visit the following Web sites to learn more about clinical research and to search for clinical trials:

• http://clinicalresearch.nih.gov
• www.clinicaltrials.gov
• www.nhlbi.nih.gov/studies/index.htm
• www.researchmatch.org

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