Viral Triggers in Pediatric Lung Transplantation

• The earliest time to BOS or OB, retransplantation or death [ Time Frame: Within 24 months of transplant ] [ Designated as safety issue: Yes ]
  

• Time to each of the following events: BOS or OB, retransplantation or death [ Time Frame: Within 24 months of transplant ] [ Designated as safety issue: Yes ]
  

Advancements in surgical techniques, preventative measures against infection, recipient selection, and new immunosuppressive regimens have improved short-term outcomes in lung transplant recipients. However, there has been no measurable improvement in long-term survival or outcomes. The cause of many adverse lung transplant outcomes may be related to respiratory viral infections (RVIs). Recent data has identified RVIs as important factors in the development of post-transplant BOS and other adverse outcomes in the pediatric lung transplant population. The purpose of this study is to determine whether respiratory viral infections increase the risk of bronchiolitis obliterans syndrome (BOS), obliterative bronchiolitis (OB), death, or retransplantation in children who have received lung transplants.

This study will enroll 80 pediatric lung transplant recipients over a period of 3 years. The study follow-up period will last 2 years. Participants will be enrolled prior to their first lung transplant.

The study will consist of 11 study visits coordinated with visits and procedures performed as part of routine care will be used. Study visits will occur prior to transplant, at transplant, weeks 2, 4, 6, months 2, 3, 6, 9, 12, 18 and 24 months after transplant.

Blood, bronchoalveolar lavage (BAL), nasal swab and/or tissue samples obtained during routine care will be used. Additional visits will occur if a participant develops symptoms of an RVI, family members and/or cohabitants are diagnosed with an RVI or an unscheduled bronchoscopy is performed for suspicion of rejection or infection.