Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-26 @ 11:10 PM
Study NCT ID:
NCT00369759
Status:
COMPLETED
Last Update Posted:
2009-03-17
First Post:
2006-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants
Sponsor:
MedImmune LLC
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: