Journal
EUROPEAN JOURNAL OF PEDIATRICS
Volume 171, Issue 5, Pages 833-841Publisher
SPRINGER
DOI: 10.1007/s00431-011-1654-8
Keywords
Respiratory syncytial virus; Palivizumab; Premature; Special populations
Categories
Funding
- Abbott Laboratories Limited
- Medimmune
- SIDS Calgary
- Alberta Centre for Child, Family & Community Research
- Alberta Law Foundation
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Palivizumab utilization, compliance, and outcomes were examined in infants with preexisting medical diseases within the Canadian Registry Database (CARESS) to aid in developing guidelines for potential at-risk infants in the future. Infants who received a parts per thousand yen1 dose of palivizumab during the 2006-2010 respiratory syncytial virus (RSV) seasons at 29 sites were recruited and utilization, compliance, and outcomes related to respiratory infection/illness (RI) events were collected monthly. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated for premature infants a parts per thousand currency sign35 completed weeks gestational age (GA) who met standard approval criteria (group 1) compared to those with medical disorders (group 2) using Cox proportional hazards regression models with adjustment for potential confounding factors. Of 7,339 registry infants, 4,880 were in group 1 and 952 in group 2, which included those with Down syndrome (20.3%), upper airway anomalies (18.7%), pulmonary diseases (13.3%), and cystic fibrosis (12.3%). Group 2 were older at enrolment (10.2 +/- 9.2 vs. 3.5 +/- 3.1 months, p < 0.0005), had higher GA (35.9 +/- 6.0 vs. 31.0 +/- 5.4 weeks, p < 0.0005), and were less compliant with treatment intervals (69.4% vs. 72.6%, p = 0.048). A greater proportion of group 2 infants were hospitalized for RI (9.0% vs. 4.2%, p < 0.0005) and RSV (2.4% vs. 1.3%, p = 0.003) (unadjusted). Being in group 2 was associated with an increased risk of RI (HR = 2.0, 95%CI 1.5-2.5, p < 0.0005), but not RSV hospitalization (HR = 1.6, 95%CI 0.9-2.8, p = 0.106). In infants receiving palivizumab, those with underlying medical disorders, though not currently approved for prophylaxis, are at higher risk for RI events compared with preterm infants. However, risk of RSV hospitalizations is similar.
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