NCT01075178

Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease

Palivizumab (Synagis®) Post-marketing Surveillance Cohort Study in Children < 24 Months of Age With Hemodynamically Significant Congenital Heart Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,036 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 24 Months
• Healthy volunteers: Not accepted

Summary

Retrospective medical record review study of specific adverse events in children with congenital heart disease who received palivizumab for prophylaxis of serious respiratory syncytial virus infection and control subjects that did not receive palivizumab

Detailed description

This is an observational, non-interventional, retrospective cohort study of infants with hemodynamically significant congenital heart disease (HSCHD) who were less than 24 months of age when the first dose of palivizumab was administered (CASES), and infants who were diagnosed with hemodynamically significant congenital heart disease but did not receive palivizumab in a historical respiratory syncytial virus (RSV) season during the first 24 months of life (CONTROLS). CASES are matched to CONTROLS based on RSV season, age, type of cardiac lesion, and type of prior corrective cardiac surgery. Subject medical records are reviewed for occurrences of the clinical end points of infection, arrhythmia, and/or death that meet criteria for serious adverse events. The groups will be compared for number and percent of subjects who experience these primary serious adverse events (both individually and collectively) during a defined 8-month chart review period.

Conditions

• Severe Respiratory Syncytial Virus Infection

Timeline

• Start date: 2006-07-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2010-02-25
• Last updated: 2011-03-23
• Results posted: 2011-02-24

Locations

37 sites across 10 countries: Austria, Belgium, France, Germany, Italy, Norway, Poland, Slovenia, Spain, United Kingdom