Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2026-01-10 @ 4:16 AM
Study NCT ID:
NCT00983606
Status:
COMPLETED
Last Update Posted:
2012-11-14
First Post:
2009-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants
Sponsor:
MedImmune LLC
Organization:
Study Overview
Official Title:
An Observational Prospective Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants (32 to 35 Week Gestational Age) - Outcomes and Risk Tracking Study (The Report Study)
Status:
COMPLETED
Status Verified Date:
2012-11
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 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.
Detailed Description:
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 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?: