Status:
COMPLETED
An Observational Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants
Lead Sponsor:
MedImmune LLC
Conditions:
Healthy
Eligibility:
All Genders
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 th...
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 ...
Eligibility Criteria
Inclusion
- Premature at birth (from 32 weeks and 0 days to 35 weeks and 6 days GA)
- Age 6 months or less at the time of screening, and born in May 2009 through January 2010 for Season 1, or May 2010 through February 2011 for Season 2
- Written informed consent and any locally required authorization (eg, HIPAA), obtained from the subject's parent/or guardian prior to performing any protocol-related procedures.
Exclusion
- Receipt of any RSV prophylactic agent: at any time prior to study participation
- Participation in studies of investigational RSV prophylaxis or RSV therapeutic agents
- Presence of bronchopulmonary dysplasia,hemodynamically significant congenital heart disease, congenital neuromuscular or congenital airway defects
- Any condition that, in the opinion of the investigator, would limit life expectancy to less than 6 months
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT00983606
Start Date
September 1 2009
End Date
July 1 2011
Last Update
November 14 2012
Active Locations (222)
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1
Research Site
Birmingham, Alabama, United States, 35209
2
Research Site
Birmingham, Alabama, United States, 35235
3
Research Site
Dothan, Alabama, United States, 36305
4
Research Site
Greenville, Alabama, United States, 36037