NCT00384462

Study to Evaluate the Incidence of Hospitalizations and Respiratory Tract Infections in Premature Infants

A Prospective, Non-Interventional Study to Evaluate the Incidence of Hospitalizations and Medically-Attended Lower Respiratory Tract Infection (MALRI) in Premature Infants 32 to 35 Weeks Gestational Age Who Are Not Recommended to Receive Prophylaxis for RSV

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 346 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 1 Month – 6 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to describe respiratory syncytial virus (RSV) hospitalization rates and to begin to address the utilization of outpatient resources for RSV medically-attended lower respiratory tract infections (MALRI) in 32-35 week gestational age (GA) premature infants who are less than 6 months of age and do not receive treatment.

Detailed description

The goals of this study are: * To estimate the incidence of hospitalization attributable to RSV within 150 days from enrollment in premature infants who are: * 32-35 weeks GA * less than 6 months of age at the start of the RSV season * not receiving palivizumab prophylaxis and not recommended to receive palivizumab according to the AAP guidelines * To estimate the incidence rate of hospitalization attributable to RSV in the other relevant study populations and time periods (e.g., Cohort 2, Cohorts 1 and 2 combined, and subgroups based on chronological age at the start of the RSV season, GA, etc. within 150 days from enrollment and other time periods based on RSV activity, etc.) * To estimate the incidence of RSV-associated MALRI in the study populations * To characterize the incidence and type of clinical interventions for MALRI in the study populations

Conditions

• Respiratory Syncytial Virus Infections

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-11-01
• Completion: 2008-01-01
• First posted: 2006-10-06
• Last updated: 2009-02-04

Locations

59 sites across 1 country: United States