Primary Outcome Measures:
- Determine palivizumab outcome measures [ Time Frame: Per respiratory syncytial virus season ] [ Designated as safety issue: No ]
The objectives of this study are:
- To determine palivizumab usage patterns, annually
- To understand palivizumab infant demographics, including: potential neonatal, familial and environmental risk factors
- To determine reasons for hospitalization, respiratory syncytial virus hospitalization rates, length of stay, morbidity and mortality
- To determine intensive care unit admissions, length of stay, use of respiratory support (e.g., mechanical ventilation, CPAP) and complication rates
- To determine compliance rates
- To collect safety data
Respiratory syncytial virus (RSV) is the most important viral respiratory pathogen in children. Infection due to RSV represents a large public health burden; in Canada, it accounts for 5,800 hospitalizations annually. The peak incidence of RSV disease occurs between 2-6 months of age with half of all infants infected in the first year of life. Palivizumab has been approved for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high-risk of RSV disease. These children include those born premature, those with bronchopulmonary dysplasia (BPD), and those with hemodynamically significant congenital heart disease (CHD).
With the recent approval of palivizumab in Canada, access to this medication has increased. However, there are limited data on utilization, compliance, and health outcomes, particularly the frequency and severity of RSV infections. The primary objective of this study is to provide insight into the current management (utilization, compliance) of children at high-risk of RSV infection with palivizumab prophylaxis in the tertiary care centers and community settings through the development of a Canadian Registry Database.