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Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01075178
First Posted: February 25, 2010
Last Update Posted: March 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
February 23, 2010
February 25, 2010
January 28, 2011
February 24, 2011
March 23, 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 ]
    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
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. ]
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
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  • 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.
Sexes Eligible for Study: All
up to 24 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   France,   Germany,   Italy,   Norway,   Poland,   Slovenia,   Spain,   United Kingdom
 
 
NCT01075178
M03-681
No
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Andrew L. Campbell, M.D., Medical Director, Abbott
Abbott
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Study Director: Andrew Campbell, MD Medical Director, Abbott Laboratories
Abbott
March 2011