OBJECTIVES: To evaluate the current management of children at high-risk of RSV infection who received palivizumab prophylaxis and were enrolled in the Canadian Registry Database. METHODS: A prospective, observational, registry of infants who received at least 1 dose of palivizumab during the 2005-2010 RSV seasons across 29 sites. Neonatal and demographic data were collected from the parent/caregiver at enrollment. Data on palivizumab utilization, compliance, and outcomes related to respiratory illness (RI) events were collected monthly. RESULTS: A total of 7699 infants were enrolled with an average age of 5.4±6.0 months. Participants were typically male (56.2%), Caucasian (71.5%) with an average gestational age (GA) of 32.2±6.0 completed weeks. A total of  5237 (68.0%) infants received palivizumab for prematurity (≤35 completed weeks GA without underlying medical disorders), 646 (8.4%) had chronic lung disease, 766 (9.9%) hemodynamically significant congenital heart disease and 1050 (13.6%) were prophylaxed for other conditions such as CNS disorders, airway anomalies and cystic fibrosis. Patients received an average of 3.9±1.6 injections and 30,040 doses overall; 5.5% of patients withdrew from the study. No direct, drug related serious adverse events were identified. 460 infants had a total of 541 RI hospitalizations resulting in a hospitalization rate of 6.0%.The overall RSV positive hospitalization (RSVH) rate was 1.47%. Living with siblings (p=0.046) and having >5 individuals in the household (p=0.007) was significantly associated with time to a patient's first RSVH. Other risk factors traditionally associated with a higher risk for RSV infection, such as gender (p=0.429), smoking (p=0.182), daycare attendance (p=0.079), age (p=0.213), and compliance with treatment (p=0.695) were not found to be significantly correlated. CONCLUSIONS: The RSVH observed from 2005-2010 was 1.4% overall (range 0.3% - 2.1%) and compares favorably with international registry data despite the steady increase in the number of Canadian immunized infants with serious underlying medical disorders.