Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01075178
First received: February 23, 2010
Last updated: March 18, 2011
Last verified: March 2011

February 23, 2010
March 18, 2011
July 2006
January 2010   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The number of subjects who died
Comparison between cases and controls of the occurrence of specific clinical outcomes of serious infection, serious arrhythmia and/or death [ Time Frame: 8-month review period in cases and controls. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01075178 on ClinicalTrials.gov Archive Site
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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

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

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

Children less than 24 months of age with hemodynamically significant congenital heart disease

Severe Respiratory Syncytial Virus Infection
Not Provided
  • Palivizumab-treated subjects (CASES)
    HSCHD infants, <2 yrs old at first dose of palivizumab
  • Non-palivizumab-treated subjects (CONTROLS)
    HSCHD infants, <2 yrs old that did not receive palivizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2036
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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).
  2. Subject must have unoperated or partially corrected congenital heart disease.
  3. 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).
  4. 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).
  5. 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:

  1. Subject was contraindicated for treatment with palivizumab according to the current European product label.
  2. Subject had full correction of Congenital Heart Disease.
  3. Subject received palivizumab before approval for use in Congenital Heart Disease (CASES), or subject received palivizumab at any time (CONTROLS).
  4. Subject has already been included in this study in a prior Respiratory Syncytial Virus season.
Both
up to 24 Months
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Poland,   United Kingdom,   Italy,   Slovenia,   Norway,   Spain,   Belgium,   France,   Austria
 
NCT01075178
M03-681
No
Andrew L. Campbell, M.D., Medical Director, Abbott
Abbott
Not Provided
Study Director: Andrew Campbell, MD Medical Director, Abbott Laboratories
Abbott
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP