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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00889070
Other study ID # MI-MA192
Secondary ID
Status Completed
Phase N/A
First received April 24, 2009
Last updated August 6, 2009
Start date November 2008
Est. completion date May 2009

Study information

Verified date August 2009
Source MedImmune LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

Assess the burden of disease associated with RSV infection with premature children in an outpatient setting.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group N/A to 6 Months
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Senders Pediatrics Cleveland Ohio
United States North Florida Pediatrics Lake City Florida
United States Children's Primary Care Medical Group, Inc. San Diego California
United States Suny Upstate Medical University Syracuse New York
United States Woburn Pediatric Associates Woburn Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Evaluate characteristics of infants in RSV risk factor and rate and reason of attrition. Seasonal: 2008-09 No
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