An Observational Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants

Completed

• Conditions: Healthy

• Registration Number: NCT00983606
• Lead Sponsor: MedImmune LLC

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-23
• Study First Submitted QC: 2009-09-23
• Study First Posted: 2009-09-24
• Primary Completion: 2011-06
• Study Completion: 2011-07
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-13
• Last Update Posted: 2012-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the incidence rate of outpatient RSV LRI during the RSV season, with RSV LRI determined by real time RT-PCR	Sep. 2009-Feb. 2010; Sep. 2010-Feb. 2011

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Monroe, Wisconsin, United States