Viral Triggers in Pediatric Lung Transplantation

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.

Inclusion Criteria:

- Parent or legal guardian willing and able to provide informed consent

- Participant of first single or bilateral heart-lung transplant

Exclusion Criteria:

- Recipient of multi-organ transplant (aside from heart-lung)

- Condition or characteristic which in the opinion of the investigator makes the
participant unlikely to complete the study