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New Study in Journal of Pediatrics Suggests Synagis (Palivizumab),May Reduce Subsequent Recurrent Wheezing in Preterm Infants

of Pediatric Infectious Diseases, University of Colorado School of Medicine and lead investigator in the study.

RSV infection usually manifests as an upper respiratory tract infection with symptoms resembling a cold. In preterm infants, however, the infection has an increased risk of progressing to a lower respiratory tract infection that sometimes requires hospitalization, mechanical ventilation and intensive care. Beyond the acute consequences of infection, epidemiologic data suggest a link between early RSV-associated hospitalization and chronic respiratory complications, such as recurrent wheezing and asthma, which may extend into adolescence.

Synagis, when administered to preterm infants as RSV prophylaxis, has previously shown a 55 percent reduction in hospitalizations due to RSV. Researchers in the current study hypothesized that Synagis, by preventing serious RSV disease, may be responsible for a reduction in recurrent wheezing later in life.

Clinical Trial Design

The study published today was conducted at 27 locations in Spain, Germany, The Netherlands, Canada, Poland and Sweden. Researchers prospectively followed a group of preterm infants (born <35 weeks gestational age) who received at least three doses of Synagis for RSV prophylaxis during their first year of life, and a matched group of preterm infants not treated with Synagis. The Synagis group consisted of 191 preterm infants who were less than 36 months of age and who were not hospitalized for RSV. The control group included 230 preterm children who were matched by chronologic and gestational age: 76 had been hospitalized for RSV and 154 had not. Study subjects were followed for 24 months beginning at a mean age of 19 months.

The primary endpoint of the study was the incidence of recurrent wheezing, defined as three or more episodes of wheezing in the preceding 12 months. An episode of wheezing was defined as one or more consecutive days of wheezing, preceded and f
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