Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369759
Status:
COMPLETED
Last Update Posted:
2009-03-17
First Post:
2006-08-24
Brief Title:
An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
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:
None
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?:
None