Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease

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

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Key information

Conditions

Severe Respiratory Syncytial Virus Infection Arrhythmias, Cardiac Cardiovascular Diseases Death Heart Diseases Infections Mononegavirales Infections Paramyxoviridae Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumovirus Infections RNA Virus Infections Respiratory Syncytial Virus Infections Virus Diseases

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Site Reference ID/Investigator# 6263, Linz, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death

Time frame: 8-month chart review period in CASES and CONTROLS

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
Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection.

Time frame: 8-month chart review period in CASES and CONTROLS

The number of subjects who experienced at least 1 event of infection meeting any of the criteria for a serious adverse event
Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Arrhythmia

Time frame: 8-month chart review period in CASES and CONTROLS

The number of subjects who experienced at least 1 event of arrhythmia meeting any of the criteria for a serious adverse event
Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death

Time frame: 8-month chart review period in CASES and CONTROLS

The number of subjects who died

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2010
Study completion: 2010
First posted: Feb 25, 2010
Registry last updated: Mar 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed