Trials / Completed
CompletedNCT00369759
An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants
An Epidemiological Study to Evaluate the Seasonality of Respiratory Syncytial Virus-Associated-Lower Respiratory Tract Infections (LRI) or Apnea in Infants in the Emergency Department
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,048 (actual)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 1 Day – 12 Months
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Emergency Dept. Subjects with LRI or Apnea | No intervention; Epidemiological Study |
Timeline
- Start date
- 2006-09-01
- Primary completion
- 2008-07-01
- Completion
- 2008-09-01
- First posted
- 2006-08-29
- Last updated
- 2009-03-17
Locations
38 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00369759. Inclusion in this directory is not an endorsement.