Each year, approximately 4,000 children undergo a tracheostomy-;the surgical placement of a breathing tube-;due to respiratory or neuromuscular disorders or chronic disease progression. Bacterial respiratory infections are the most common reason for hospitalization of these children at a cost of $300 million in U. S. hospital charges. In spite of its frequency, there is very limited evidence on how best to prevent, diagnose and treat bacterial respiratory infection in these children. Christopher Russell, MD, MS, a pediatric hospitalist at Children's Hospital Los Angeles, will lead the first multicenter prospective study of respiratory infection in children with tracheostomy.

We know that bacterial respiratory infection occurs frequently in kids who have tracheostomies. Some clinicians prospectively start patients on broad-spectrum antibiotics while others wait for culture results and treat the specific organism. This study will provide information about which option produces the best clinical outcomes while reducing unnecessary antibiotic use and cost of care."

Dr. Christopher Russell, Principal Investigator at The Saban Research Institute

The study will evaluate the outcomes of 1,500 children with tracheostomy, from newborn to 21 years of age, hospitalized at five participating children's hospitals. The study team will monitor the impact of factors like rapid viral testing, antibiotic initiation prior to the results of testing and the type of antibiotics used. The investigators are also interested in how test results and other clinical factors influence physicians' decisions about continuing antibiotic use.

The study team aims to provide clinical practice guidelines for the prevention, diagnosis and management of bacterial infections in pediatric patients with tracheostomy. "Our study will give us much needed evidence to proactively help these kids," says Dr. Russell, "while providing information to support a randomized controlled trial for therapeutic interventions."

Study co-investigators include Michael Neely, MD, Chief of Infectious Diseases at CHLA, Tamara Simon, MD, MSPH, Pediatric Hospitalist at CHLA and Wendy Mack, PhD, of the Department of Population and Public Health Sciences at the Keck School of Medicine of USC. In addition to Children's Hospital Los Angeles, participating sites include:

• Seattle Children's Hospital
• Cincinnati Children's Hospital Medical Center
• Children's National Medical Center
• Johns Hopkins All Children's Hospital

The current study was funded by the Agency for Healthcare Research and Quality, part of the Department of Health and Human Services. This study builds upon Dr. Russell's earlier work funded by the The Gerber Foundation.