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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01075178 |
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Date of registration:
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23/02/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease
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Scientific title:
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Palivizumab (Synagis®) Post-marketing Surveillance Cohort Study in Children < 24 Months of Age With Hemodynamically Significant Congenital Heart Disease |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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2036 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01075178 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Austria
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Belgium
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France
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Germany
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Italy
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Norway
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Poland
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Slovenia
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Spain
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United Kingdom
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Contacts
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Name:
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Andrew Campbell, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical Director, Abbott Laboratories |
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
24 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Severe Respiratory Syncytial Virus Infection
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Primary Outcome(s)
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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]
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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]
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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]
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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