Why Include Children in Research?

You may wonder why children are included in research since it involves uncertainty and may have risks. Why not ask adults only, who can decide for themselves if they want to join a study?

Children are different from adults

Research is usually done with adults first. Many medicines and treatments have been studied only in adults. Because children's bodies are different than adults', children sometimes don't respond to medicine and treatments in the same way that adults do. For example, the correct dose of a medicine for a child cannot be decided by simply decreasing the adult dose to match the child's size. When studies were done on a seizure medicine called Neurontin, it showed that children less than 5 years of age needed a larger dose of the medicine to prevent seizures. Also, side effects of some medicines only happen in children. For example, Tetracycline, an antibiotic, when given to young children, can stain their teeth. Giving aspirin to children with viruses is linked to Reye’s syndrome .

Some problems occur only in children and cannot be tested in adults like congenital heart defects and prematurity. For children to benefit from new medicines and treatments, it's important to include them in research studies. In 1998, the National Institutes of Health (NIH) made a policy that children should be included in all NIH-supported research unless there are good reasons to leave them out. In 2002, Congress approved the Best Pharmaceuticals for Children Act which helps drug companies to do studies of certain medicines that are used in children but have not been studied in children.

Research helps children

Many children today benefit from research that was done on children in the past. For example, the ways that doctors treat many childhood cancers and cystic fibrosis are based on past research. The Pediatric Heart Network (PHN) was established in 2001 to conduct research in children with congenital heart defects and heart disease in order to improve their health and quality of life. One area of research is in Kawasaki Disease (KD) . The cause of KD is not known. From 1984-1991, the National Heart, Lung, and Blood Institute (NHLBI) funded a large study which found that intravenous gamma globulin (IVGG) combined with aspirin was more effective than aspirin alone in preventing out-pouching areas in heart arteries (aneurysms ) in children with KD. This really changed how doctors treated children with KD. Very few children are seen today with aneurysms. The PHN has recently finished a study on the effects of IVGG and steroids together to see if the number of aneurysms went down even more.

The goal for the PHN study teams is to conduct research that will help children who have heart defects or disease, today and in the future, have better and healthier lives.