Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Severe Respiratory Syncytial Virus Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must have documented hemodynamically significant congenital heart disease (Note: Children with uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus are not eligible). Subject must have unoperated or partially corrected congenital heart disease. Subject must have received at least one dose of palivizumab for prophylaxis during the Respiratory Syncytial Virus season - September 1 through April 30 (CASES), or would have been considered eligible for palivizumab prophylaxis (CONTROLS). Subject must be < 24 months of age at the time of the first dose of palivizumab prophylaxis (CASES) or < 32 months of age at the end of the assigned Respiratory Syncytial Virus season in which they would have been eligible to receive palivizumab if the drug had been approved in the European Union (CONTROLS). Subject's parent, guardian, or legal representative has voluntarily signed and dated a Release of Information Form to allow the review of medical records and collection of pertinent study data. Exclusion Criteria: Subject was contraindicated for treatment with palivizumab according to the current European product label. Subject had full correction of Congenital Heart Disease. Subject received palivizumab before approval for use in Congenital Heart Disease (CASES), or subject received palivizumab at any time (CONTROLS). Subject has already been included in this study in a prior Respiratory Syncytial Virus season.

Ages Eligible for Study
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Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Palivizumab-treated subjects (CASES)<br>HSCHD infants, <2 yrs old at first dose of palivizumab | |
| Non-palivizumab-treated subjects (CONTROLS)<br>HSCHD infants, <2 yrs old that did not receive palivizumab | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death | The number of subjects who experienced at least 1 event of infection, arrhythmia, or death meeting any of the criteria for a serious adverse event | 8-month chart review period in CASES and CONTROLS | 
| Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection. | The number of subjects who experienced at least 1 event of infection meeting any of the criteria for a serious adverse event | 8-month chart review period in CASES and CONTROLS | 
| Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Arrhythmia | The number of subjects who experienced at least 1 event of arrhythmia meeting any of the criteria for a serious adverse event | 8-month chart review period in CASES and CONTROLS | 
| Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death | The number of subjects who died | 8-month chart review period in CASES and CONTROLS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infection, Arrhythmia, Death, Palivizumab, Safety, Hemodynamically Significant Congenital Heart Disease, Pediatric, Observational