What is the Pediatric Heart Network (PHN)?

The Pediatric Heart Network (PHN) is a collaboration of clinical sites and a data coordinating center that conduct research studies in children with congenital or acquired heart disease . The PHN was created and funded in 2001 by the National Heart, Lung and Blood Institute to improve outcomes and quality of life in children with heart disease. Centers with experienced research teams at hospitals that specialize in the care of pediatric patients with heart disease were chosen to become part of the PHN.

Congenital cardiovascular malformations affect approximately 40,000 infants in the United States each year, and are a leading cause of infant death. The incidence of congenital heart disease is at least triple that of childhood cancers, and is substantially greater than pediatric AIDS. In the past 25 years, fewer than 40 randomized clinical trials have been carried out in patients with congenital or acquired heart disease and nearly half of these dealt only with a patent ductus arteriosus in preterm infants.

The major barriers to clinical studies in pediatric heart disease include the variety of conditions, the small numbers of individuals with a particular congenital heart defect at any one center, differences in treatment approaches between centers, absence of systematic centralized databases, and lack of resources to provide national coordination of collaborative efforts. Additional barriers relate to parents being unaware of studies, living a distance from a research site, or lacking familiarity with what happens during a study.

The Network approach attempts to address these barriers by offering an effective, flexible way to study adequate numbers of patients with uncommon diseases through a common infrastructure for recruiting, monitoring, and following patients whose conditions will be characterized in a standard fashion. A collaborative effort through a clinical research Network is the most scientifically sound and cost-effective way to overcome the current barriers and to provide the information needed to bring evidence-based medicine to bear on children with heart disease. A Network also provides a platform to train junior investigators in pediatric clinical research, and serves as a vehicle for rapid and widespread dissemination of findings.

All of the centers carefully follow a study protocol , collect identical data and treat patients in similar ways (See How Studies are Created and Monitored). The PHN centers use similar brochures and consent forms to share with families who may want to enter a study. PHN nurses and doctors are experienced in the care of children with heart disease and the conduct of clinical studies. They have undergone Human Subjects Research training as required by the National Institutes of Health (NIH) as well as training in study conduct for each protocol in the PHN.

As a healthcare provider, you may wish to discuss a study with one of your patients or to refer a patient for consideration for study enrollment. Study requirements, inclusion/exclusion criteria, endpoints and general protocol information can be found under Current Studies. Patients referred to a PHN study continue to be managed by their primary cardiologist. Arrangements will be made to allow the PHN research team to interact frequently with the primary cardiologist in order to coordinate tests or visits and to ascertain adverse events. When available, unblinded results from study tests will be given to the primary cardiologists.