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)

MedImmune LLC1 site in 1 country3,000 target enrollmentSeptember 2009

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: MedImmune LLC
Enrollment: 3000
Locations: 1
Primary Endpoint: The primary endpoint is the incidence rate of outpatient RSV LRI during the RSV season, with RSV LRI determined by real time RT-PCR
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

July 2011

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

MedImmune LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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

Outcomes

Primary Outcomes

The primary endpoint is the incidence rate of outpatient RSV LRI during the RSV season, with RSV LRI determined by real time RT-PCR

Time Frame: Sep. 2009-Feb. 2010; Sep. 2010-Feb. 2011

Secondary Outcomes

Rate of risk factors for RSV-associated outpatient LRI, hospitalization, and ED visits(2009-2010; 2010-2011)
Rate of risk factors for RSV infection(2009-2010; 2010-2011)
Rate of RSV-associated emergency department (ED) visits during the RSV season(2009-2010; 2010- 2011)
Rate of RSV-associated hospitalization during the RSV season(2009-2010; 2010-2011)