Objective: The Palivizumab Outcomes Registry contains data on infants and young children who received palivizumab for the prevention of respiratory syncytial virus (RSV) that causes serious lower respiratory tract illness.Study Design: Prospective observational registry enrolling those who received X1 dose of palivizumab during any RSV season (2000 to 2004) at participating US sites.Result: Of 19 548 subjects enrolled, 40% were born before 32 weeks', 48% between 32 and 35 weeks' and 12% after 35 weeks' gestation. Risk factors included child-care attendance, prematurity, chronic lung disease (CLD) and congenital heart disease (CHD). The RSV hospitalization rate of palivizumab recipients was 1.3%. Gender, gestational age <32 weeks, CLD, CHD, congenital airway abnormality, severe neuromuscular disease, Medicaid insurance and >2 children in household were associated with significantly higher rates. Home-care prophylaxis with palivizumab was associated with reduced hospitalization rates.Conclusion: Data on the use of palivizumab prophylaxis in primarily high-risk infants confirm low RSV hospitalization rates.

The Palivizumab Outcomes Registry collected data on 19,548 high-risk infants who received > or =1 dose of palivizumab and followed prospectively from 2000 through 2004. Ninety-one children with cystic fibrosis (CF) were identified who received palivizumab off label. None of the infants with CF who received prophylaxis was hospitalized as a result of respiratory syncytial virus lower respiratory tract infection. Evaluations of palivizumab use in infants with CF could be warranted.

Background:Annual respiratory syncytial virus (RSV) outbreaks throughout the US exhibit variable patterns in onset, peak month of activity and duration of season. RSVAlert®, a US surveillance system, collects and characterizes RSV test data at national, regional, state and local levels.Methods:RSV test data from 296 to 666 laboratories from 50 states, the District of Columbia and Puerto Rico (as of 2010) were collected during the 2007–2008 to 2011–2012 RSV seasons. Data were collected in early August/September to the following August/September each season. Participating laboratories provided the total number and types of RSV tests performed each week and test results. RSV season onset and offset were defined as the first and last, respectively, of 2 consecutive weeks during which the mean percentage of specimens testing positive for RSV was ≥10%.Results:Nationally, the RSV season onset occurred in October/November of each year with offset occurring in March/April of the following year. The RSV season averaged 20 weeks and typically occurred earliest in the South and latest in the West. The onset, offset and duration varied considerably within the US Department of Health and Human Services regions. RSV activity in Puerto Rico was elevated throughout the 2-year period studied. Median onset in core-based statistical areas ranged from 2 weeks earlier to 5 weeks later than those in their corresponding states.Conclusions:Substantial variability existed in the timing of RSV activity at all geographic strata analyzed. RSV actively circulated (ie, ≥10%) in many areas outside the traditionally defined RSV epidemic period of November to March.

Although antigen detection was the predominant test type reported in the sample of US hospital laboratories for RSV testing, PCR use increased to >20% of tests reported. These results demonstrate the increasing contribution of PCR to RSV surveillance. RSV surveillance systems relying solely on antigen detection results will not capture an increasing proportion of RSV test results.

The Palivizumab Outcomes Registry prospectively collected data on 19,548 subjects who received respiratory syncytial virus (RSV) prophylaxis with palivizumab during the 2000-2004 RSV seasons. We evaluated the characteristics of enrolled registry subjects with congenital heart disease (CHD) over the four RSV seasons and examined additional information on these subjects collected in the 2002-2004 seasons. The percentage of registry subjects with CHD increased from 4.8% (102/2116) in the first season to 11.4% (688/6050) in the last season. Across all four seasons, 1500 subjects with CHD were enrolled, 71% of whom had acyanotic CHD. The proportion with cyanotic CHD increased from 19.6% (20/102) in the 2000-2001 season to 37.5% (258/688) in the 2003-2004 season, while the proportion of all CHD in the registry more than doubled during this time. The cumulative RSV hospitalization rate was 1.9% among patients with CHD who received prophylaxis. Among subjects with cyanotic and acyanotic CHD, hospitalization rates were 2.6% and 1.6%, respectively. Prospective data collected in the Palivizumab Outcomes Registry provide the largest published dataset available on infants with CHD receiving palivizumab and show low hospitalization rates and use consistent with prelicensure clinical trial data and revised American Academy of Pediatrics guidelines.