Respiratory Syncytial Virus
Conditions
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 visits and hospitalization among preterm infants (32-≤36 wGA) during RSV season, and its medical/health consequences, as measured by wheezing events, the infant's first RSV season, up to May 2009.
Interventions
None listed
Sponsors
MedImmune LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of RSV positivity and rate of outpatient and/or inpatient LRI events as well as the rate of outpatient and inpatient wheezing events. | Seasonal: 2008-09 |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate characteristics of infants in RSV risk factor and rate and reason of attrition. | Seasonal: 2008-09 |
Countries
United States
Outcome results
None listed