A comparative study of respiratory syncytial virus (RSV) prophylaxis in premature infants within the Canadian Registry of Palivizumab (CARESS)

Eur J Clin Microbiol Infect Dis. 2012 Oct;31(10):2703-11. doi: 10.1007/s10096-012-1617-7. Epub 2012 May 1.

Abstract

We examined the dosing regimens, compliance, and outcomes of premature infants who received palivizumab within the Canadian Registry of Palivizumab (CARESS). Infants receiving ≥1 dose of palivizumab during the 2006-2011 respiratory syncytial virus (RSV) seasons were recruited across 30 sites. Respiratory illness events were captured monthly. Infants ≤32 completed weeks gestational age (GA) (Group 1) were compared to 33-35 completed weeks GA infants (Group 2) following prophylaxis. In total, 6,654 patients were analyzed (Group 1, n = 5,183; Group 2, n = 1,471). The mean GA was 29.9 ± 2.9 versus 34.2 ± 2.2 weeks for Groups 1 and 2, respectively. Group differences were significant (all p-values <0.05) for the following: proportion of males, Caucasians, siblings, multiple births, maternal smoking, smoking during pregnancy, household smokers, >5 household individuals, birth weight, and enrolment age. Overall, infants received 92.6 % of expected injections. Group 1 received significantly more injections, but a greater proportion of Group 2 received injections within recommended intervals. The hospitalization rates were similar for Groups 1 and 2 for respiratory illness (4.7 % vs. 3.7 %, p = 0.1) and RSV (1.5 % vs. 1.4 %, p = 0.3). Neither the time to first respiratory illness [hazard ratio = 0.9, 95 % confidence interval (CI) 0.7-1.2, p = 0.5] nor to first RSV hospitalization (hazard ratio = 1.3, 95 % CI 0.8-2.2, p = 0.3) were different. Compliance with RSV prophylaxis is high. Despite the higher number of palivizumab doses in infants ≤32 completed weeks GA, the two groups' respiratory illness and RSV-positive hospitalization rates were similar.

Publication types

  • Comparative Study

MeSH terms

  • Antibodies, Monoclonal, Humanized / administration & dosage*
  • Antiviral Agents / administration & dosage
  • Birth Weight
  • Canada / epidemiology
  • Female
  • Gestational Age
  • Hospitalization / statistics & numerical data
  • Humans
  • Infant, Newborn
  • Infant, Premature*
  • Male
  • Palivizumab
  • Pregnancy
  • Proportional Hazards Models
  • Registries
  • Respiratory Syncytial Virus Infections / epidemiology
  • Respiratory Syncytial Virus Infections / prevention & control*
  • Respiratory Syncytial Virus Infections / virology
  • Respiratory Syncytial Virus, Human / pathogenicity*
  • Seasons
  • Smoking / adverse effects
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal, Humanized
  • Antiviral Agents
  • Palivizumab