Trials / Completed
CompletedNCT00983606
An Observational Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,000 (estimated)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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.
Conditions
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2011-06-01
- Completion
- 2011-07-01
- First posted
- 2009-09-24
- Last updated
- 2012-11-14
Locations
222 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00983606. Inclusion in this directory is not an endorsement.