Objective: To determine current usage of palivizumab prophylaxis, the compliance patterns, hospitalization rates and outcomes in children at high-risk of respiratory syncytial virus (RSV) infection through the development of a Canadian Registry Database (CARESS). Methods: A prospective, longitudinal, observational, follow-up study of Canadian infants who received palivizumab prophylaxis in the 2006/2007 RSV season. Neonatal and demographic data were collected from the parent/caregiver upon enrollment. Parents/caregivers were contacted monthly (at next injection or by telephone) by site nurses for data on palivizumab utilization and compliance, and outcomes related to any respiratory tract events. Results: Information was collected on 1224 infants who received at least one injection of palivizumab and who ranged in age from 2 days to 34 months (mean = 5.17 months). Participating children were typically male (57.4%) and Caucasian (72.2%). Gestational age was 31.5 ± 4.3 weeks. 914 infants (74.7%) received palivizumab primarily for prematurity (=35 completed weeks gestational age), 119 (9.7%) had bronchopulmonary dysplasia and required supportive oxygen therapy, 119 (9.7%) had congenital heart disease and 72 (5.9%) were prophylaxed for other risk factors. A total of 76.9% of subjects received at least 4 injections of palivizumab, with a total of 5355 doses, overall. The majority of injections were administered within the recommended monthly time intervals (73.5%). There was a 5.1% hospitalization rate for respiratory tract events (e.g., bronchiolitis or pneumonia). The RSV positive hospitalization rate was 1.2% (proven RSV). Hospitalization rates for respiratory tract events were highest in those with bronchopulmonary dysplasia (12.8%, p<.001), and in those of Hispanic (15.4%) or Aboriginal descent (13.6%)(p=.051). Conclusion: Compliance with the course of palivizumab therapy was very good. The RSV hospitalization rate observed in the 2006/2007 CARESS season was lower than that previously documented in the scientific literature.