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Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease

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ClinicalTrials.gov Identifier: NCT01075178
Recruitment Status : Completed
First Posted : February 25, 2010
Results First Posted : February 24, 2011
Last Update Posted : March 23, 2011
Sponsor:
Information provided by:

Study Description
Brief 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

Condition or disease
Severe Respiratory Syncytial Virus Infection

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.

Study Design

Study Type : Observational
Actual Enrollment : 2036 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Palivizumab (Synagis®) Post-marketing Surveillance Cohort Study in Children < 24 Months of Age With Hemodynamically Significant Congenital Heart Disease
Study Start Date : July 2006
Primary Completion Date : January 2010
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Palivizumab
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Eligibility Criteria

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children less than 24 months of age with hemodynamically significant congenital heart disease
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075178


  Show 37 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Andrew Campbell, MD Medical Director, Abbott Laboratories
More Information

Additional Information:
Responsible Party: Andrew L. Campbell, M.D., Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT01075178     History of Changes
Other Study ID Numbers: M03-681
First Posted: February 25, 2010    Key Record Dates
Results First Posted: February 24, 2011
Last Update Posted: March 23, 2011
Last Verified: March 2011

Keywords provided by Abbott:
Infection
Arrhythmia
Death
Palivizumab
Safety
Hemodynamically Significant Congenital Heart Disease
Pediatric
Observational

Additional relevant MeSH terms:
Heart Diseases
Virus Diseases
Heart Defects, Congenital
Respiratory Syncytial Virus Infections
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Palivizumab
Antiviral Agents
Anti-Infective Agents