• Patrizio Pezzotti, Jessica Mantovani, Nicoletta Benincori, Eleonora Mucchino, and Domenico Di Lallo.
• Agency for Public Health of Lazio region, Scientific Direction unit, Rome, Italy. Pezzotti@asplazio.it
• Bmc Pediatr. 2009 Jan 1; 9: 56.

BackgroundBronchiolitis is a distressing, potentially life-threatening respiratory condition that affects infants. We evaluated the incidence and risk factors of hospitalization for broncholitis in preterm infants (i.e., a gestational age of <36 weeks) born between 2000 and 2006, and the use and impact of Palivizumab, a monoclonal antibody that in randomized clinical trials has been shown to lessen the severity of RSV-related bronchiolitis.MethodsRetrospective cohort study that linked data from four health administrative databases in the Lazio region (a region of central Italy): the birth register, the hospital discharge register, and two ad-hoc databases that record the doses of Palivizumab administered at two local health units.ResultsAmong 2407 preterm infants, 137 had at least one hospitalization for bronchiolitis in the first 18 months of life, an overall incidence rate of 4.70 per 100 person-years (95%CI: 3.98-5.56); similar incidence rates were observed by calendar year. A multiple Poisson model showed that the following characteristics were associated with higher incidence: younger age of the infant, the period between October-April, male gender, low Apgar score at birth, low birth weight, and low maternal educational level. At least one dose of Palivizumab was administered to 324 (13.5%) children; a dramatic increase from 2000 (2.8%) to 2006 (19.1%) (p < 0.01) was observed. Other factors independently associated with more frequent Palivizumab use were older maternal age, Italian-born mothers, female gender, low Apgar score, low birth weight, shorter gestational age, a diagnosis of broncho-dysplasia, and the month of birth. It is of note that none of the 34 children with congenital heart disease were prescribed Palivizumab. Performing several multiple Poisson models that also considered Palivizumab use as covariate, although the point estimates were in agreement with previous clinical trial results, we did not find in most of them a significant reduction for immunized children to be hospitalized for bronchiolitis.ConclusionIn Italy the incidence of hospitalization for bronchiolitis, and its associated risk factors, are similar to that found in other countries. Although Palivizumab use is associated with the most important characteristics of severe prematurity, other aspects of its non-use in children with congenital heart disease, the age and the birth country of the mother suggest the need for public health measures that can reduce these health disparities. Finally, the estimated effectiveness of Palivizumab in routine practice, although not significant, confirms the results of previous clinical trials, but its impact on modifying the temporal trend in this population is still negligible.

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