The primary objective is to assess the burden of respiratory disease in outpatient settings among 32 to 35 weeks' gestational age (wGA) infants in the USA who did not receive RSV prophylaxis during the infants' first RSV season.
The primary objective is to determine the burden of RSV disease in outpatient settings among 32 to 35 wGA infants in the USA who did not receive RSV prophylaxis, as measured by rate of RSV-associated outpatient lower respiratory tract illness (LRI) during the infants' first RSV season.
Study Type
OBSERVATIONAL
Enrollment
3,000
The primary endpoint is the incidence rate of outpatient RSV LRI during the RSV season, with RSV LRI determined by real time RT-PCR
Time frame: Sep. 2009-Feb. 2010; Sep. 2010-Feb. 2011
Rate of RSV-associated emergency department (ED) visits during the RSV season
Time frame: 2009-2010; 2010- 2011
Rate of RSV-associated hospitalization during the RSV season
Time frame: 2009-2010; 2010-2011
Rate of risk factors for RSV-associated outpatient LRI, hospitalization, and ED visits
Time frame: 2009-2010; 2010-2011
Rate of risk factors for RSV infection
Time frame: 2009-2010; 2010-2011
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Research Site
Birmingham, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Dothan, Alabama, United States
Research Site
Greenville, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Prattville, Alabama, United States
Research Site
Scottsboro, Alabama, United States
Research Site
Selma, Alabama, United States
Research Site
Sylacauga, Alabama, United States
Research Site
Tuscaloosa, Alabama, United States
...and 212 more locations