Palivizumab efficacy in preterm infants with gestational age < or = 30 weeks without bronchopulmonary dysplasia.

The present study was designed to determine the efficacy of administration of palivizumab to preterm infants with gestational age (GA) < or = 30 weeks without bronchopulmonary dysplasia (BPD). All patients born with GA < or = 30 weeks without BPD on Day 28 and hospitalized for RSV bronchiolitis in Burgundy (12 hospitals) from December 1 to April 30 of the next year were included in this prospective observational study during five successive RSV seasons (1999-2000, 2000-2001, 2001-2002, 2002-2003, and 2003-2004). Palivizumab was given to premature infants with a gestational age < or = 30 weeks without BPD in the 2002-2003 and 2003-2004 periods only. In the cohort of premature infants with GA < or = 30 weeks without BPD, the respiratory syncytial virus (RSV) bronchiolitis hospitalization rate was reduced significantly (P < 0.01) in the two seasons with palivizumab prophylaxis (2002-2003: 0% and 2003-2004: 2%) versus the three previous RSV seasons (1999-2000: 14.3%; 2000-2001: 16.7%; 2001-2002: 10.2%). The number needed to treat to prevent one hospitalization for RSV bronchiolitis was 6 (95%CI: 4-11). Such favorable results have not been always found in the few available postmarketing epidemiological studies on hospitalization rate after palivizumab prophylaxis. Differences in health care organization could explain those discrepancies. 2007 Wiley-Liss, Inc.