Status:
COMPLETED
Respiratory Events Among Premature Infants
Lead Sponsor:
MedImmune LLC
Conditions:
Respiratory Syncytial Virus
Eligibility:
All Genders
Up to 6 years
Brief Summary
Assess the burden of disease associated with RSV infection with premature children in an outpatient setting.
Detailed Description
The primary objective of this prospective study is to assess the burden of disease associated with RSV infection, as measured/determined by rates of outpatient medically attended LRI, emergency room v...
Eligibility Criteria
Inclusion
- Written informed consent from parent/guardian to participate in study
- Male or female preterm infants 32-≤36 wGA
- Infant is ≤ 6month old at the time of enrollment
- Parent/guardian has the ability and willingness to follow study protocol (during the first RSV season) as required by the protocol
Exclusion
- Receipt of any RSV prophylactic agent: palivizumab, IGIV, or motavizumab at any time prior to enrollment
- Participation in trials of investigational RSV prophylaxis or RSV therapeutic agents
- Presence of BPD or CHD (other than surgically treated PDA, ASD or VSD)
- Condition that limits life span to 6 months or less from the date of enrollment
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00889070
Start Date
November 1 2008
End Date
May 1 2009
Last Update
August 7 2009
Active Locations (5)
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1
Children's Primary Care Medical Group, Inc.
San Diego, California, United States, 92120
2
North Florida Pediatrics
Lake City, Florida, United States, 32025
3
Woburn Pediatric Associates
Woburn, Massachusetts, United States, 18013
4
Suny Upstate Medical University
Syracuse, New York, United States, 13120