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Clinical Trial Summary

The primary objective of this study is to describe the incidence of RSV-associated LRI among infants <1 year of age presenting to the ED during selected shoulder months.


Clinical Trial Description

- The primary objective of this study is to describe the incidence of RSV-associated LRI or apnea (% RSV positive) among infants <1 year of age presenting to the ED during selected shoulder months. The total number of events will also be described.

- To characterize the clinical outcomes and demographic data of infants presenting to the ED with RSV-associated LRI or apnea

- To characterize the social burden (in the form of number of days lost from work by parent/ guardian) for these infants through 14 days after the index ED visit and through hospital discharge will also be described.

- Based on a sample of cases collected in a cohort of patients enrolled at or near the peak of RSV disease during the traditional season, a comparison of the rate of RSV between shoulder and peak periods will be described.

- To describe the overall rates of RSV-associated LRI or apnea based on the general ED statistics collected during the entire study period. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00369759
Study type Observational
Source MedImmune LLC
Contact
Status Completed
Phase N/A
Start date September 2006
Completion date September 2008

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